Ultrasonic energy device which varies pressure applied by clamp arm to provide threshold control pressure at a cut progression location

ABSTRACT

Surgical instruments and system and methods for using surgical instruments are disclosed. A surgical instrument comprises an end effector comprising an ultrasonic blade and clamp arm, an ultrasonic transducer, and a control circuit. The ultrasonic transducer ultrasonically oscillates the ultrasonic blade in response to a drive signal from a generator. The end effector receives electrosurgical energy to weld tissue. The control circuit determines a resonant frequency measure indicative of a thermally induced change in resonant frequency and a electrical continuity measure; calculates a weld focal point based on the determined measures, controls closure of the clamp arm to vary a pressure applied by the clamp arm to provide a threshold control pressure to the tissue loaded into the end effector, and maintains a gap between the ultrasonic blade and clamp arm at a point proximal to the proximal end of the tissue. Pressure is varied based on corresponding weld focal point.

CROSS REFERENCE TO RELATED APPLICATIONS

The present application claims priority under 35 U.S.C. § 119(e) to U.S.Provisional Patent Application No. 62/729,195, titled ULTRASONIC ENERGYDEVICE WHICH VARIES PRESSURE APPLIED BY CLAMP ARM TO PROVIDE THRESHOLDCONTROL PRESSURE ATA CUT PROGRESSION LOCATION, filed on Sep. 10, 2018,the disclosure of which is herein incorporated by reference in itsentirety.

The present application also claims priority under 35 U.S.C. § 119(e) toU.S. Provisional Patent Application No. 62/692,747, titled SMARTACTIVATION OF AN ENERGY DEVICE BY ANOTHER DEVICE, filed on Jun. 30,2018, to U.S. Provisional Patent Application No. 62/692,748, titledSMART ENERGY ARCHITECTURE, filed on Jun. 30, 2018, and to U.S.Provisional Patent Application No. 62/692,768, titled SMART ENERGYDEVICES, filed on Jun. 30, 2018, the disclosure of each of which isherein incorporated by reference in its entirety.

The present application also claims priority under 35 U.S.C. § 119(e) toU.S. Provisional Patent Application No. 62/659,900, titled METHOD OF HUBCOMMUNICATION, filed on Apr. 19, 2018, the disclosure of each of whichis herein incorporated by reference in its entirety.

The present application also claims priority under 35 U.S.C. § 119(e) toU.S. Provisional Patent Application No. 62/650,898 filed on Mar. 30,2018, titled CAPACITIVE COUPLED RETURN PATH PAD WITH SEPARABLE ARRAYELEMENTS, to U.S. Provisional Patent Application Ser. No. 62/650,887,titled SURGICAL SYSTEMS WITH OPTIMIZED SENSING CAPABILITIES, filed Mar.30, 2018, to U.S. Provisional Patent Application Ser. No. 62/650,882,titled SMOKE EVACUATION MODULE FOR INTERACTIVE SURGICAL PLATFORM, filedMar. 30, 2018, and to U.S. Provisional Patent Application Ser. No.62/650,877, titled SURGICAL SMOKE EVACUATION SENSING AND CONTROLS, filedMar. 30, 2018, the disclosure of each of which is herein incorporated byreference in its entirety.

The present application also claims priority under 35 U.S.C. § 119(e) toU.S. Provisional Patent Application Ser. No. 62/640,417, titledTEMPERATURE CONTROL IN ULTRASONIC DEVICE AND CONTROL SYSTEM THEREFOR,filed Mar. 8, 2018, and to U.S. Provisional Patent Application Ser. No.62/640,415, titled ESTIMATING STATE OF ULTRASONIC END EFFECTOR ANDCONTROL SYSTEM THEREFOR, filed Mar. 8, 2018, the disclosure of each ofwhich is herein incorporated by reference in its entirety.

The present application also claims priority under 35 U.S.C. § 119(e) toU.S. Provisional Patent Application Ser. No. 62/611,341, titledINTERACTIVE SURGICAL PLATFORM, filed Dec. 28, 2017, to U.S. ProvisionalPatent Application Ser. No. 62/611,340, titled CLOUD-BASED MEDICALANALYTICS, filed Dec. 28, 2017, and to U.S. Provisional PatentApplication Ser. No. 62/611,339, titled ROBOT ASSISTED SURGICALPLATFORM, filed Dec. 28, 2017, the disclosure of each of which is hereinincorporated by reference in its entirety.

BACKGROUND

The present disclosure relates to various surgical systems. Surgicalprocedures are typically performed in surgical operating theaters orrooms in a healthcare facility such as, for example, a hospital. Asterile field is typically created around the patient. The sterile fieldmay include the scrubbed team members, who are properly attired, and allfurniture and fixtures in the area. Various surgical devices and systemsare utilized in performance of a surgical procedure.

FIGURES

The various aspects described herein, both as to organization andmethods of operation, together with further objects and advantagesthereof, may best be understood by reference to the followingdescription, taken in conjunction with the accompanying drawings asfollows.

FIG. 1 is a block diagram of a computer-implemented interactive surgicalsystem, in accordance with at least one aspect of the presentdisclosure.

FIG. 2 is a surgical system being used to perform a surgical procedurein an operating room, in accordance with at least one aspect of thepresent disclosure.

FIG. 3 is a surgical hub paired with a visualization system, a roboticsystem, and an intelligent instrument, in accordance with at least oneaspect of the present disclosure.

FIG. 4 is a partial perspective view of a surgical hub enclosure, and ofa combo generator module slidably receivable in a drawer of the surgicalhub enclosure, in accordance with at least one aspect of the presentdisclosure.

FIG. 5 is a perspective view of a combo generator module with bipolar,ultrasonic, and monopolar contacts and a smoke evacuation component, inaccordance with at least one aspect of the present disclosure.

FIG. 6 illustrates individual power bus attachments for a plurality oflateral docking ports of a lateral modular housing configured to receivea plurality of modules, in accordance with at least one aspect of thepresent disclosure.

FIG. 7 illustrates a vertical modular housing configured to receive aplurality of modules, in accordance with at least one aspect of thepresent disclosure.

FIG. 8 illustrates a surgical data network comprising a modularcommunication hub configured to connect modular devices located in oneor more operating theaters of a healthcare facility, or any room in ahealthcare facility specially equipped for surgical operations, to thecloud, in accordance with at least one aspect of the present disclosure.

FIG. 9 illustrates a computer-implemented interactive surgical system,in accordance with at least one aspect of the present disclosure.

FIG. 10 illustrates a surgical hub comprising a plurality of modulescoupled to the modular control tower, in accordance with at least oneaspect of the present disclosure.

FIG. 11 illustrates one aspect of a Universal Serial Bus (USB) networkhub device, in accordance with at least one aspect of the presentdisclosure.

FIG. 12 is a block diagram of a cloud computing system comprising aplurality of smart surgical instruments coupled to surgical hubs thatmay connect to the cloud component of the cloud computing system, inaccordance with at least one aspect of the present disclosure.

FIG. 13 is a functional module architecture of a cloud computing system,in accordance with at least one aspect of the present disclosure.

FIG. 14 illustrates a diagram of a situationally aware surgical system,in accordance with at least one aspect of the present disclosure.

FIG. 15 is a timeline depicting situational awareness of a surgical hub,in accordance with at least one aspect of the present disclosure.

FIG. 16 is a schematic diagram of a robotic surgical instrumentconfigured to operate a surgical tool described herein, in accordancewith at least one aspect of the present disclosure.

FIG. 17 illustrates a block diagram of a surgical instrument programmedto control the distal translation of a displacement member, inaccordance with at least one aspect of the present disclosure.

FIG. 18 is a schematic diagram of a surgical instrument configured tocontrol various functions, in accordance with at least one aspect of thepresent disclosure.

FIG. 19 illustrates an example of a generator, in accordance with atleast one aspect of the present disclosure.

FIG. 20 is a structural view of a generator architecture, in accordancewith at least one aspect of the present disclosure.

FIG. 21 illustrates a generator circuit partitioned into multiple stageswhere a first stage circuit is common to the second stage circuit, inaccordance with at least one aspect of the present disclosure.

FIG. 22 illustrates a diagram of one aspect of a surgical instrumentcomprising a feedback system for use with a surgical instrument,according to one aspect of the present disclosure.

FIG. 23A-23B are graphs including a graph of clamp force as a functionof time and an associated graph of a coagulation/cut focal point, inaccordance with at least one aspect of the present disclosure.

FIGS. 24A-24B are graphs including a graph of clamp force as a functionof distance from the distal tip of the end effector and a graph of bladedisplacement as a function of distance from the distal tip, inaccordance with at least one aspect of the present disclosure.

FIG. 25 is a graph of a clamp force distribution as a function ofvarious sections along the length of the end effector, in accordancewith at least one aspect of the present disclosure.

FIG. 26 is a graph of blade displacement profile as a function ofdistance from the distal tip of the end effector, in accordance with atleast one aspect of the present disclosure.

FIGS. 27A-27C are sectional views of end effector that illustrate aclosure stroke of the end effector, in accordance with at least oneaspect of the present disclosure.

FIGS. 28A-28C are graphs of clamp force applied between the blade andclamp arm as a function of distance from the distal tip of the endeffector corresponding to the sectional views of FIGS. 27A-27C, inaccordance with at least one aspect of the present disclosure.

FIGS. 29A-29C are sectional views of the end effector that illustrate aproximal start closure stroke configuration, in accordance with at leastone aspect of the present disclosure.

FIGS. 30A-30D are sectional views of the end effector that illustrate adistal start closure stroke configuration and indicate associated partstresses, in accordance with at least one aspect of the presentdisclosure.

FIGS. 31A-31D are graphs of clamp force applied between the ultrasonicblade and clamp arm as a function of distance from the distal tip of theend effector corresponding to the sectional views of FIGS. 30A-30D, inaccordance with at least one aspect of the present disclosure.

FIG. 32A-32E are sectional views of the end effector that illustrate adistal start closure stroke configuration and indicate associated partstresses, in accordance with at least one aspect of the presentdisclosure.

DESCRIPTION

Applicant of the present application owns the following U.S. PatentApplications, filed on Nov. 6, 2018, the disclosure of each of which isherein incorporated by reference in its entirety:

-   -   U.S. patent application Ser. No. 16/182,224, titled SURGICAL        NETWORK, INSTRUMENT, AND CLOUD RESPONSES BASED ON VALIDATION OF        RECEIVED DATASET AND AUTHENTICATION OF ITS SOURCE AND INTEGRITY,        now U.S. Pat. No. 11,308,075;    -   U.S. patent application Ser. No. 14/182,230, titled SURGICAL        SYSTEM FOR PRESENTING INFORMATION INTERPRETED FROM EXTERNAL        DATA, now U.S. Patent Application Publication No. 2019/0200980;    -   U.S. patent application Ser. No. 16/182,233, titled SURGICAL        SYSTEMS WITH AUTONOMOUSLY ADJUSTABLE CONTROL PROGRAMS, now U.S.        Patent Application Publication No. 2019/0201123;    -   U.S. patent application Ser. No. 14/182,239, titled ADJUSTMENT        OF DEVICE CONTROL PROGRAMS BASED ON STRATIFIED CONTEXTUAL DATA        IN ADDITION TO THE DATA, now U.S. Patent Application Publication        No. 2019/0201124;    -   U.S. patent application Ser. No. 16/182,243, titled SURGICAL HUB        AND MODULAR DEVICE RESPONSE ADJUSTMENT BASED ON SITUATIONAL        AWARENESS, now U.S. Pat. No. 11,273,001;    -   U.S. patent application Ser. No. 16/182,248, titled DETECTION        AND ESCALATION OF SECURITY RESPONSES OF SURGICAL INSTRUMENTS TO        INCREASING SEVERITY THREATS, now U.S. Pat. No. 10,943,454;    -   U.S. patent application Ser. No. 16/182,251, titled INTERACTIVE

SURGICAL SYSTEM, now U.S. Pat. No. 11,278,281;

-   -   U.S. patent application Ser. No. 16/182,260, titled AUTOMATED        DATA SCALING, ALIGNMENT, AND ORGANIZING BASED ON PREDEFINED        PARAMETERS WITHIN SURGICAL NETWORKS, now U.S. Pat. No.        11,056,244;    -   U.S. patent application Ser. No. 14/182,267, titled SENSING THE        PATIENT POSITION AND CONTACT UTILIZING THE MONO-POLAR RETURN PAD        ELECTRODE TO PROVIDE SITUATIONAL AWARENESS TO THE HUB, now U.S.        Patent Application Publication No. 2019/0201128;    -   U.S. patent application Ser. No. 16/182,249, titled POWERED        SURGICAL TOOL WITH PREDEFINED ADJUSTABLE CONTROL ALGORITHM FOR        CONTROLLING END EFFECTOR PARAMETER, now U.S. Pat. No.        11,234,756;    -   U.S. patent application Ser. No. 14/182,246, titled ADJUSTMENTS        BASED ON AIRBORNE PARTICLE PROPERTIES, now U.S. Patent        Application Publication No. 2019/0204201;    -   U.S. patent application Ser. No. 16/182,256, titled ADJUSTMENT        OF A SURGICAL DEVICE FUNCTION BASED ON SITUATIONAL AWARENESS,        now U.S. Patent Application Publication No. 2019/0201127;    -   U.S. patent application Ser. No. 16/182,242, titled REAL-TIME        ANALYSIS OF COMPREHENSIVE COST OF ALL INSTRUMENTATION USED IN        SURGERY UTILIZING DATA FLUIDITY TO TRACK INSTRUMENTS THROUGH        STOCKING AND IN-HOUSE PROCESSES, now U.S. Pat. No. 11,257,589;    -   U.S. patent application Ser. No. 16/182,255, titled USAGE AND        TECHNIQUE ANALYSIS OF SURGEON/STAFF PERFORMANCE AGAINST A        BASELINE TO OPTIMIZE DEVICE UTILIZATION AND PERFORMANCE FOR BOTH        CURRENT AND FUTURE PROCEDURES, now U.S. Patent Application        Publication No. 2019/0201126;    -   U.S. patent application Ser. No. 16/182,269, titled IMAGE        CAPTURING OF THE AREAS OUTSIDE THE ABDOMEN TO IMPROVE PLACEMENT        AND CONTROL OF A SURGICAL DEVICE IN USE, now U.S. Pat. No.        11,304,763;    -   U.S. patent application Ser. No. 14/182,278, titled        COMMUNICATION OF DATA WHERE A SURGICAL NETWORK IS USING CONTEXT        OF THE DATA AND REQUIREMENTS OF A RECEIVING SYSTEM/USER TO        INFLUENCE INCLUSION OR LINKAGE OF DATA AND METADATA TO ESTABLISH        CONTINUITY, now U.S. Patent Application Publication No.        2019/0201130;    -   U.S. patent application Ser. No. 16/182,290, titled SURGICAL        NETWORK RECOMMENDATIONS FROM REAL TIME ANALYSIS OF PROCEDURE        VARIABLES AGAINST A BASELINE HIGHLIGHTING DIFFERENCES FROM THE        OPTIMAL SOLUTION, now U.S. Patent Application Publication No.        2019/0201102;    -   U.S. patent Application Ser. No. 16/182,232, titled CONTROL OF A        SURGICAL SYSTEM THROUGH A SURGICAL BARRIER, now U.S. Patent        Application Publication No. 2019/0201158;    -   U.S. patent application Ser. No. 16/182,227, titled SURGICAL        NETWORK DETERMINATION OF PRIORITIZATION OF COMMUNICATION,        INTERACTION, OR PROCESSING BASED ON SYSTEM OR DEVICE NEEDS, now        U.S. Pat. No. 10,892,995;    -   U.S. patent application Ser. No. 16/182,231, titled WIRELESS        PAIRING OF A SURGICAL DEVICE WITH ANOTHER DEVICE WITHIN A        STERILE SURGICAL FIELD BASED ON THE USAGE AND SITUATIONAL        AWARENESS OF DEVICES, now U.S. Pat. No. 10,758,310;    -   U.S. patent application Ser. No. 16/182,229, titled ADJUSTMENT        OF STAPLE HEIGHT OF AT LEAST ONE ROW OF STAPLES BASED ON THE        SENSED TISSUE THICKNESS OR FORCE IN CLOSING, now U.S. Pat. No.        11,096,693;    -   U.S. patent application Ser. No. 16/182,234, titled STAPLING        DEVICE WITH BOTH COMPULSORY AND DISCRETIONARY LOCKOUTS BASED ON        SENSED PARAMETERS, now U.S. Patent Application Publication No.        2019/0200997;    -   U.S. patent application Ser. No. 16/182,240, titled POWERED        STAPLING DEVICE CONFIGURED TO ADJUST FORCE, ADVANCEMENT SPEED,        AND OVERALL STROKE OF CUTTING MEMBER BASED ON SENSED PARAMETER        OF FIRING OR CLAMPING, now U.S. Patent Application Publication        No. 2019/0201034; and    -   U.S. patent application Ser. No. 16/182,235, titled VARIATION OF        RADIO FREQUENCY AND ULTRASONIC POWER LEVEL IN COOPERATION WITH        VARYING CLAMP ARM PRESSURE TO ACHIEVE PREDEFINED HEAT FLUX OR        POWER APPLIED TO TISSUE, now U.S. Patent Application Publication        No. 2019/0201044.

Applicant of the present application owns the following U.S. patentapplications, filed on Sep. 10, 2018, the disclosure of each of which isherein incorporated by reference in its entirety:

-   -   U.S. Provisional Patent Application No. 62/729,183, titled A        CONTROL FOR A SURGICAL NETWORK OR SURGICAL NETWORK CONNECTED        DEVICE THAT ADJUSTS ITS FUNCTION BASED ON A SENSED SITUATION OR        USAGE;    -   U.S. Provisional Patent Application No. 62/729,177, titled        AUTOMATED DATA SCALING, ALIGNMENT, AND ORGANIZING BASED ON        PREDEFINED PARAMETERS WITHIN A SURGICAL NETWORK BEFORE        TRANSMISSION;    -   U.S. Provisional Patent Application No. 62/729,176, titled        INDIRECT COMMAND AND CONTROL OF A FIRST OPERATING ROOM SYSTEM        THROUGH THE USE OF A SECOND OPERATING ROOM SYSTEM WITHIN A        STERILE FIELD WHERE THE SECOND OPERATING ROOM SYSTEM HAS PRIMARY        AND SECONDARY OPERATING MODES;    -   U.S. Provisional Patent Application No. 62/729,185, titled        POWERED STAPLING DEVICE THAT IS CAPABLE OF ADJUSTING FORCE,        ADVANCEMENT SPEED, AND OVERALL STROKE OF CUTTING MEMBER OF THE        DEVICE BASED ON SENSED PARAMETER OF FIRING OR CLAMPING;    -   U.S. Provisional Patent Application No. 62/729,184, titled        POWERED SURGICAL TOOL WITH A PREDEFINED ADJUSTABLE CONTROL        ALGORITHM FOR CONTROLLING AT LEAST ONE END EFFECTOR PARAMETER        AND A MEANS FOR LIMITING THE ADJUSTMENT;    -   U.S. Provisional Patent Application No. 62/729,182, titled        SENSING THE PATIENT POSITION AND CONTACT UTILIZING THE MONO        POLAR RETURN PAD ELECTRODE TO PROVIDE SITUATIONAL AWARENESS TO        THE HUB;    -   U.S. Provisional Patent Application No. 62/729,191, titled        SURGICAL NETWORK RECOMMENDATIONS FROM REAL TIME ANALYSIS OF        PROCEDURE VARIABLES AGAINST A BASELINE HIGHLIGHTING DIFFERENCES        FROM THE OPTIMAL SOLUTION;    -   U.S. Provisional Patent Application No. 62/729,195, titled        ULTRASONIC ENERGY DEVICE WHICH VARIES PRESSURE APPLIED BY CLAMP        ARM TO PROVIDE THRESHOLD CONTROL PRESSURE AT A CUT PROGRESSION        LOCATION; and    -   U.S. Provisional Patent Application No. 62/729,186, titled        WIRELESS PAIRING OF A SURGICAL DEVICE WITH ANOTHER DEVICE WITHIN        A STERILE SURGICAL FIELD BASED ON THE USAGE AND SITUATIONAL        AWARENESS OF DEVICES.

Applicant of the present application owns the following U.S. patentapplications, filed on Aug. 28, 2018, the disclosure of each of which isherein incorporated by reference in its entirety:

-   -   U.S. patent application Ser. No. 16/115,214, titled ESTIMATING        STATE OF ULTRASONIC END EFFECTOR AND CONTROL SYSTEM THEREFOR;    -   U.S. patent application Ser. No. 16/115,205, titled TEMPERATURE        CONTROL OF ULTRASONIC END EFFECTOR AND CONTROL SYSTEM THEREFOR;    -   U.S. patent application Ser. No. 16/115,233, titled RADIO        FREQUENCY ENERGY DEVICE FOR DELIVERING COMBINED ELECTRICAL        SIGNALS;    -   U.S. patent application Ser. No. 16/115,208, titled CONTROLLING        AN ULTRASONIC SURGICAL INSTRUMENT ACCORDING TO TISSUE LOCATION;    -   U.S. patent application Ser. No. 16/115,220, titled CONTROLLING        ACTIVATION OF AN ULTRASONIC SURGICAL INSTRUMENT ACCORDING TO THE        PRESENCE OF TISSUE;    -   U.S. patent application Ser. No. 16/115,232, titled DETERMINING        TISSUE COMPOSITION VIA AN ULTRASONIC SYSTEM;    -   U.S. patent application Ser. No. 16/115,239, titled DETERMINING        THE STATE OF AN ULTRASONIC ELECTROMECHANICAL SYSTEM ACCORDING TO        FREQUENCY SHIFT;    -   U.S. patent application Ser. No. 16/115,247, titled DETERMINING        THE STATE OF AN ULTRASONIC END EFFECTOR;    -   U.S. patent application Ser. No. 16/115,211, titled SITUATIONAL        AWARENESS OF ELECTROSURGICAL SYSTEMS;    -   U.S. patent application Ser. No. 16/115,226, titled MECHANISMS        FOR CONTROLLING DIFFERENT ELECTROMECHANICAL SYSTEMS OF AN        ELECTROSURGICAL INSTRUMENT;    -   U.S. patent application Ser. No. 16/115,240, titled DETECTION OF        END EFFECTOR IMMERSION IN LIQUID;    -   U.S. patent application Ser. No. 16/115,249, titled INTERRUPTION        OF ENERGY DUE TO INADVERTENT CAPACITIVE COUPLING;    -   U.S. patent application Ser. No. 16/115,256, titled INCREASING        RADIO FREQUENCY TO CREATE PAD-LESS MONOPOLAR LOOP;    -   U.S. patent application Ser. No. 16/115,223, titled BIPOLAR        COMBINATION DEVICE THAT AUTOMATICALLY ADJUSTS PRESSURE BASED ON        ENERGY MODALITY; and    -   U.S. patent application Ser. No. 16/115,238, titled ACTIVATION        OF ENERGY DEVICES.

Applicant of the present application owns the following U.S. patentapplications, filed on Aug. 23, 2018, the disclosure of each of which isherein incorporated by reference in its entirety:

-   -   U.S. Provisional Patent Application No. 62/721,995, titled        CONTROLLING AN ULTRASONIC SURGICAL INSTRUMENT ACCORDING TO        TISSUE LOCATION;    -   U.S. Provisional Patent Application No. 62/721,998, titled        SITUATIONAL AWARENESS OF ELECTROSURGICAL SYSTEMS;    -   U.S. Provisional Patent Application No. 62/721,999, titled        INTERRUPTION OF ENERGY DUE TO INADVERTENT CAPACITIVE COUPLING;    -   U.S. Provisional Patent Application No. 62/721,994, titled        BIPOLAR COMBINATION DEVICE THAT AUTOMATICALLY ADJUSTS PRESSURE        BASED ON ENERGY MODALITY; and    -   U.S. Provisional Patent Application No. 62/721,996, titled RADIO        FREQUENCY ENERGY DEVICE FOR DELIVERING COMBINED ELECTRICAL        SIGNALS.

Applicant of the present application owns the following U.S. patentapplications, filed on Jun. 30, 2018, the disclosure of each of which isherein incorporated by reference in its entirety:

-   -   U.S. Provisional Patent Application No. 62/692,747, titled SMART        ACTIVATION OF AN ENERGY DEVICE BY ANOTHER DEVICE;    -   U.S. Provisional Patent Application No. 62/692,748, titled SMART        ENERGY ARCHITECTURE; and    -   U.S. Provisional Patent Application No. 62/692,768, titled SMART        ENERGY DEVICES.

Applicant of the present application owns the following U.S. patentapplications, filed on Jun. 29, 2018, the disclosure of each of which isherein incorporated by reference in its entirety:

-   -   U.S. patent application Ser. No. 16/024,090, titled CAPACITIVE        COUPLED RETURN PATH PAD WITH SEPARABLE ARRAY ELEMENTS;    -   U.S. patent application Ser. No. 16/024,057, titled CONTROLLING        A SURGICAL INSTRUMENT ACCORDING TO SENSED CLOSURE PARAMETERS;    -   U.S. patent application Ser. No. 16/024,067, titled SYSTEMS FOR        ADJUSTING END EFFECTOR PARAMETERS BASED ON PERIOPERATIVE        INFORMATION;    -   U.S. patent application Ser. No. 16/024,075, titled SAFETY        SYSTEMS FOR SMART POWERED SURGICAL STAPLING;    -   U.S. patent application Ser. No. 16/024,083, titled SAFETY        SYSTEMS FOR SMART POWERED SURGICAL STAPLING;    -   U.S. patent application Ser. No. 16/024,094, titled SURGICAL        SYSTEMS FOR DETECTING END EFFECTOR TISSUE DISTRIBUTION        IRREGULARITIES;    -   U.S. patent application Ser. No. 16/024,138, titled SYSTEMS FOR        DETECTING PROXIMITY OF SURGICAL END EFFECTOR TO CANCEROUS        TISSUE;    -   U.S. patent application Ser. No. 16/024,150, titled SURGICAL        INSTRUMENT CARTRIDGE SENSOR ASSEMBLIES;    -   U.S. patent application Ser. No. 16/024,160, titled VARIABLE        OUTPUT CARTRIDGE SENSOR ASSEMBLY;    -   U.S. patent application Ser. No. 16/024,124, titled SURGICAL        INSTRUMENT HAVING A FLEXIBLE ELECTRODE;    -   U.S. patent application Ser. No. 16/024,132, titled SURGICAL        INSTRUMENT HAVING A FLEXIBLE CIRCUIT;    -   U.S. patent application Ser. No. 16/024,141, titled SURGICAL        INSTRUMENT WITH A TISSUE MARKING ASSEMBLY;    -   U.S. patent application Ser. No. 16/024,162, titled SURGICAL        SYSTEMS WITH PRIORITIZED DATA TRANSMISSION CAPABILITIES;    -   U.S. patent application Ser. No. 16/024,066, titled SURGICAL        EVACUATION SENSING AND MOTOR CONTROL;    -   U.S. patent application Ser. No. 16/024,096, titled SURGICAL        EVACUATION SENSOR ARRANGEMENTS;    -   U.S. patent application Ser. No. 16/024,116, titled SURGICAL        EVACUATION FLOW PATHS;    -   U.S. patent application Ser. No. 16/024,149, titled SURGICAL        EVACUATION SENSING AND GENERATOR CONTROL;    -   U.S. patent application Ser. No. 16/024,180, titled SURGICAL        EVACUATION SENSING AND DISPLAY;    -   U.S. patent application Ser. No. 16/024,245, titled        COMMUNICATION OF SMOKE EVACUATION SYSTEM PARAMETERS TO HUB OR        CLOUD IN SMOKE EVACUATION MODULE FOR INTERACTIVE SURGICAL        PLATFORM;    -   U.S. patent application Ser. No. 16/024,258, titled SMOKE        EVACUATION SYSTEM INCLUDING A SEGMENTED CONTROL CIRCUIT FOR        INTERACTIVE SURGICAL PLATFORM;    -   U.S. patent application Ser. No. 16/024,265, titled SURGICAL        EVACUATION SYSTEM WITH A COMMUNICATION CIRCUIT FOR COMMUNICATION        BETWEEN A FILTER AND A SMOKE EVACUATION DEVICE; and    -   U.S. patent application Ser. No. 16/024,273, titled DUAL        IN-SERIES LARGE AND SMALL DROPLET FILTERS.

Applicant of the present application owns the following U.S. Provisionalpatent applications, filed on Jun. 28, 2018, the disclosure of each ofwhich is herein incorporated by reference in its entirety:

-   -   U.S. Provisional Patent Application Ser. No. 62/691,228, titled        A METHOD OF USING REINFORCED FLEX CIRCUITS WITH MULTIPLE SENSORS        WITH ELECTROSURGICAL DEVICES;    -   U.S. Provisional Patent Application Ser. No. 62/691,227, titled        CONTROLLING A SURGICAL INSTRUMENT ACCORDING TO SENSED CLOSURE        PARAMETERS;    -   U.S. Provisional Patent Application Ser. No. 62/691,230, titled        SURGICAL INSTRUMENT HAVING A FLEXIBLE ELECTRODE;    -   U.S. Provisional Patent Application Ser. No. 62/691,219, titled        SURGICAL EVACUATION SENSING AND MOTOR CONTROL;    -   U.S. Provisional Patent Application Ser. No. 62/691,257, titled        COMMUNICATION OF SMOKE EVACUATION SYSTEM PARAMETERS TO HUB OR        CLOUD IN SMOKE EVACUATION MODULE FOR INTERACTIVE SURGICAL        PLATFORM;    -   U.S. Provisional Patent Application Ser. No. 62/691,262, titled        SURGICAL EVACUATION SYSTEM WITH A COMMUNICATION CIRCUIT FOR        COMMUNICATION BETWEEN A FILTER AND A SMOKE EVACUATION DEVICE;        and    -   U.S. Provisional Patent Application Ser. No. 62/691,251, titled        DUAL IN-SERIES LARGE AND SMALL DROPLET FILTERS.

Applicant of the present application owns the following U.S. Provisionalpatent application, filed on Apr. 19, 2018, the disclosure of which isherein incorporated by reference in its entirety:

-   -   U.S. Provisional Patent Application Ser. No. 62/659,900, titled        METHOD OF HUB COMMUNICATION.

Applicant of the present application owns the following U.S. Provisionalpatent applications, filed on Mar. 30, 2018, the disclosure of each ofwhich is herein incorporated by reference in its entirety:

-   -   U.S. Provisional Patent Application No. 62/650,898 filed on Mar.        30, 2018, titled CAPACITIVE COUPLED RETURN PATH PAD WITH        SEPARABLE ARRAY ELEMENTS;    -   U.S. Provisional Patent Application Ser. No. 62/650,887, titled        SURGICAL SYSTEMS WITH OPTIMIZED SENSING CAPABILITIES;    -   U.S. Provisional Patent Application Ser. No. 62/650,882, titled        SMOKE EVACUATION MODULE FOR INTERACTIVE SURGICAL PLATFORM; and    -   U.S. Provisional Patent Application Ser. No. 62/650,877, titled        SURGICAL SMOKE EVACUATION SENSING AND CONTROLS.

Applicant of the present application owns the following U.S. patentapplications, filed on Mar. 29, 2018, the disclosure of each of which isherein incorporated by reference in its entirety:

-   -   U.S. patent application Ser. No. 15/940,641, titled INTERACTIVE        SURGICAL SYSTEMS WITH ENCRYPTED COMMUNICATION CAPABILITIES;    -   U.S. patent application Ser. No. 15/940,648, titled INTERACTIVE        SURGICAL SYSTEMS WITH CONDITION HANDLING OF DEVICES AND DATA        CAPABILITIES;    -   U.S. patent application Ser. No. 15/940,656, titled SURGICAL HUB        COORDINATION OF CONTROL AND COMMUNICATION OF OPERATING ROOM        DEVICES;    -   U.S. patent application Ser. No. 15/940,666, titled SPATIAL        AWARENESS OF SURGICAL HUBS IN OPERATING ROOMS;    -   U.S. patent application Ser. No. 15/940,670, titled COOPERATIVE        UTILIZATION OF DATA DERIVED FROM SECONDARY SOURCES BY        INTELLIGENT SURGICAL HUBS;    -   U.S. patent application Ser. No. 15/940,677, titled SURGICAL HUB        CONTROL ARRANGEMENTS;    -   U.S. patent application Ser. No. 15/940,632, titled DATA        STRIPPING METHOD TO INTERROGATE PATIENT RECORDS AND CREATE        ANONYMIZED RECORD;    -   U.S. patent application Ser. No. 15/940,640, titled        COMMUNICATION HUB AND STORAGE DEVICE FOR STORING PARAMETERS AND        STATUS OF A SURGICAL DEVICE TO BE SHARED WITH CLOUD BASED        ANALYTICS SYSTEMS;    -   U.S. patent application Ser. No. 15/940,645, titled SELF        DESCRIBING DATA PACKETS GENERATED AT AN ISSUING INSTRUMENT;    -   U.S. patent application Ser. No. 15/940,649, titled DATA PAIRING        TO INTERCONNECT A DEVICE MEASURED PARAMETER WITH AN OUTCOME;    -   U.S. patent application Ser. No. 15/940,654, titled SURGICAL HUB        SITUATIONAL AWARENESS;    -   U.S. patent application Ser. No. 15/940,663, titled SURGICAL        SYSTEM DISTRIBUTED PROCESSING;    -   U.S. patent application Ser. No. 15/940,668, titled AGGREGATION        AND REPORTING OF SURGICAL HUB DATA;    -   U.S. patent application Ser. No. 15/940,671, titled SURGICAL HUB        SPATIAL AWARENESS TO DETERMINE DEVICES IN OPERATING THEATER;    -   U.S. patent application Ser. No. 15/940,686, titled DISPLAY OF        ALIGNMENT OF STAPLE CARTRIDGE TO PRIOR LINEAR STAPLE LINE;    -   U.S. patent application Ser. No. 15/940,700, titled STERILE        FIELD INTERACTIVE CONTROL DISPLAYS;    -   U.S. patent application Ser. No. 15/940,629, titled COMPUTER        IMPLEMENTED INTERACTIVE SURGICAL SYSTEMS;    -   U.S. patent application Ser. No. 15/940,704, titled USE OF LASER        LIGHT AND RED-GREEN-BLUE COLORATION TO DETERMINE PROPERTIES OF        BACK SCATTERED LIGHT;    -   U.S. patent application Ser. No. 15/940,722, titled        CHARACTERIZATION OF TISSUE IRREGULARITIES THROUGH THE USE OF        MONO-CHROMATIC LIGHT REFRACTIVITY;    -   U.S. patent application Ser. No. 15/940,742, titled DUAL CMOS        ARRAY IMAGING;    -   U.S. patent application Ser. No. 15/940,636, titled ADAPTIVE        CONTROL PROGRAM UPDATES FOR SURGICAL DEVICES;    -   U.S. patent application Ser. No. 15/940,653, titled ADAPTIVE        CONTROL PROGRAM UPDATES FOR SURGICAL HUBS;    -   U.S. patent application Ser. No. 15/940,660, titled CLOUD-BASED        MEDICAL ANALYTICS FOR CUSTOMIZATION AND RECOMMENDATIONS TO A        USER;    -   U.S. patent application Ser. No. 15/940,679, titled CLOUD-BASED        MEDICAL ANALYTICS FOR LINKING OF LOCAL USAGE TRENDS WITH THE        RESOURCE ACQUISITION BEHAVIORS OF LARGER DATA SET;    -   U.S. patent application Ser. No. 15/940,694, titled CLOUD-BASED        MEDICAL ANALYTICS FOR MEDICAL FACILITY SEGMENTED        INDIVIDUALIZATION OF INSTRUMENT FUNCTION;    -   U.S. patent application Ser. No. 15/940,634, titled CLOUD-BASED        MEDICAL ANALYTICS FOR SECURITY AND AUTHENTICATION TRENDS AND        REACTIVE MEASURES;    -   U.S. patent application Ser. No. 15/940,706, titled DATA        HANDLING AND PRIORITIZATION IN A CLOUD ANALYTICS NETWORK;    -   U.S. patent application Ser. No. 15/940,675, titled CLOUD        INTERFACE FOR COUPLED SURGICAL DEVICES;    -   U.S. patent application Ser. No. 15/940,627, titled DRIVE        ARRANGEMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS;    -   U.S. patent application Ser. No. 15/940,637, titled        COMMUNICATION ARRANGEMENTS FOR ROBOT-ASSISTED SURGICAL        PLATFORMS;    -   U.S. patent application Ser. No. 15/940,642, titled CONTROLS FOR        ROBOT-ASSISTED SURGICAL PLATFORMS;    -   U.S. patent application Ser. No. 15/940,676, titled AUTOMATIC        TOOL ADJUSTMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS;    -   U.S. patent application Ser. No. 15/940,680, titled CONTROLLERS        FOR ROBOT-ASSISTED SURGICAL PLATFORMS;    -   U.S. patent application Ser. No. 15/940,683, titled COOPERATIVE        SURGICAL ACTIONS FOR ROBOT-ASSISTED SURGICAL PLATFORMS;    -   U.S. patent application Ser. No. 15/940,690, titled DISPLAY        ARRANGEMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS; and    -   U.S. patent application Ser. No. 15/940,711, titled SENSING        ARRANGEMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS.

Applicant of the present application owns the following U.S. Provisionalpatent applications, filed on Mar. 28, 2018, the disclosure of each ofwhich is herein incorporated by reference in its entirety:

-   -   U.S. Provisional Patent Application Ser. No. 62/649,302, titled        INTERACTIVE SURGICAL SYSTEMS WITH ENCRYPTED COMMUNICATION        CAPABILITIES;    -   U.S. Provisional Patent Application Ser. No. 62/649,294, titled        DATA STRIPPING METHOD TO INTERROGATE PATIENT RECORDS AND CREATE        ANONYMIZED RECORD;    -   U.S. Provisional Patent Application Ser. No. 62/649,300, titled        SURGICAL HUB SITUATIONAL AWARENESS;    -   U.S. Provisional Patent Application Ser. No. 62/649,309, titled        SURGICAL HUB SPATIAL AWARENESS TO DETERMINE DEVICES IN OPERATING        THEATER;    -   U.S. Provisional Patent Application Ser. No. 62/649,310, titled        COMPUTER IMPLEMENTED INTERACTIVE SURGICAL SYSTEMS;    -   U.S. Provisional Patent Application Ser. No. 62/649,291, titled        USE OF LASER LIGHT AND RED-GREEN-BLUE COLORATION TO DETERMINE        PROPERTIES OF BACK SCATTERED LIGHT;    -   U.S. Provisional Patent Application Ser. No. 62/649,296, titled        ADAPTIVE CONTROL PROGRAM UPDATES FOR SURGICAL DEVICES;    -   U.S. Provisional Patent Application Ser. No. 62/649,333, titled        CLOUD-BASED MEDICAL ANALYTICS FOR CUSTOMIZATION AND        RECOMMENDATIONS TO A USER;    -   U.S. Provisional Patent Application Ser. No. 62/649,327, titled        CLOUD-BASED MEDICAL ANALYTICS FOR SECURITY AND AUTHENTICATION        TRENDS AND REACTIVE MEASURES;    -   U.S. Provisional Patent Application Ser. No. 62/649,315, titled        DATA HANDLING AND PRIORITIZATION IN A CLOUD ANALYTICS NETWORK;    -   U.S. Provisional Patent Application Ser. No. 62/649,313, titled        CLOUD INTERFACE FOR COUPLED SURGICAL DEVICES;    -   U.S. Provisional Patent Application Ser. No. 62/649,320, titled        DRIVE ARRANGEMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS;    -   U.S. Provisional Patent Application Ser. No. 62/649,307, titled        AUTOMATIC TOOL ADJUSTMENTS FOR ROBOT-ASSISTED SURGICAL        PLATFORMS; and    -   U.S. Provisional Patent Application Ser. No. 62/649,323, titled        SENSING ARRANGEMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS.

Applicant of the present application owns the following U.S. Provisionalpatent applications, filed on Mar. 8, 2018, the disclosure of each ofwhich is herein incorporated by reference in its entirety:

-   -   U.S. Provisional Patent Application Ser. No. 62/640,417, titled        TEMPERATURE CONTROL IN ULTRASONIC DEVICE AND CONTROL SYSTEM        THEREFOR; and    -   U.S. Provisional Patent Application Ser. No. 62/640,415, titled        ESTIMATING STATE OF ULTRASONIC END EFFECTOR AND CONTROL SYSTEM        THEREFOR.

Applicant of the present application owns the following U.S. Provisionalpatent applications, filed on Dec. 28, 2017, the disclosure of each ofwhich is herein incorporated by reference in its entirety:

-   -   U.S. Provisional patent application Serial No. U.S. Provisional        Patent Application Ser. No. 62/611,341, titled INTERACTIVE        SURGICAL PLATFORM;    -   U.S. Provisional Patent Application Ser. No. 62/611,340, titled        CLOUD-BASED MEDICAL ANALYTICS; and    -   U.S. Provisional Patent Application Ser. No. 62/611,339, titled        ROBOT ASSISTED SURGICAL PLATFORM.

Before explaining various aspects of surgical devices and generators indetail, it should be noted that the illustrative examples are notlimited in application or use to the details of construction andarrangement of parts illustrated in the accompanying drawings anddescription. The illustrative examples may be implemented orincorporated in other aspects, variations and modifications, and may bepracticed or carried out in various ways. Further, unless otherwiseindicated, the terms and expressions employed herein have been chosenfor the purpose of describing the illustrative examples for theconvenience of the reader and are not for the purpose of limitationthereof. Also, it will be appreciated that one or more of thefollowing-described aspects, expressions of aspects, and/or examples,can be combined with any one or more of the other following-describedaspects, expressions of aspects and/or examples.

Surgical Hubs

Referring to FIG. 1, a computer-implemented interactive surgical system100 includes one or more surgical systems 102 and a cloud-based system(e.g., the cloud 104 that may include a remote server 113 coupled to astorage device 105). Each surgical system 102 includes at least onesurgical hub 106 in communication with the cloud 104 that may include aremote server 113. In one example, as illustrated in FIG. 1, thesurgical system 102 includes a visualization system 108, a roboticsystem 110, and a handheld intelligent surgical instrument 112, whichare configured to communicate with one another and/or the hub 106. Insome aspects, a surgical system 102 may include an M number of hubs 106,an N number of visualization systems 108, an O number of robotic systems110, and a P number of handheld intelligent surgical instruments 112,where M, N, O, and P are integers greater than or equal to one.

In various aspects, the intelligent instruments 112 as described hereinwith reference to FIGS. 1-7 may be implemented as ultrasonic surgicalinstruments and combination energy surgical instruments 7012 asdescribed in FIGS. 23A-23B, 24A-24B, 25-26, 27A-27C, 28A-28C, 29A-29C,30A-30D, 31A-31D, 32A-32E. The intelligent instruments 112 (e.g.,devices 1 a-1 n) such as ultrasonic/combination surgical instruments7012 as described in FIGS. 23A-23B, 24A-24B, 25-26, 27A-27C, 28A-28C,29A-29C, 30A-30D, 31A-31D, 32A-32E are configured to operate in asurgical data network 201 as described with reference to FIG. 8.

FIG. 2 depicts an example of a surgical system 102 being used to performa surgical procedure on a patient who is lying down on an operatingtable 114 in a surgical operating room 116. A robotic system 110 is usedin the surgical procedure as a part of the surgical system 102. Therobotic system 110 includes a surgeon's console 118, a patient side cart120 (surgical robot), and a surgical robotic hub 122. The patient sidecart 120 can manipulate at least one removably coupled surgical tool 117through a minimally invasive incision in the body of the patient whilethe surgeon views the surgical site through the surgeon's console 118.An image of the surgical site can be obtained by a medical imagingdevice 124, which can be manipulated by the patient side cart 120 toorient the imaging device 124. The robotic hub 122 can be used toprocess the images of the surgical site for subsequent display to thesurgeon through the surgeon's console 118.

Other types of robotic systems can be readily adapted for use with thesurgical system 102. Various examples of robotic systems and surgicaltools that are suitable for use with the present disclosure aredescribed in U.S. Provisional Patent Application Ser. No. 62/611,339,titled ROBOT ASSISTED SURGICAL PLATFORM, filed Dec. 28, 2017, thedisclosure of which is herein incorporated by reference in its entirety.

Various examples of cloud-based analytics that are performed by thecloud 104, and are suitable for use with the present disclosure, aredescribed in U.S. Provisional Patent Application Ser. No. 62/611,340,titled CLOUD-BASED MEDICAL ANALYTICS, filed Dec. 28, 2017, thedisclosure of which is herein incorporated by reference in its entirety.

In various aspects, the imaging device 124 includes at least one imagesensor and one or more optical components. Suitable image sensorsinclude, but are not limited to, Charge-Coupled Device (CCD) sensors andComplementary Metal-Oxide Semiconductor (CMOS) sensors.

The optical components of the imaging device 124 may include one or moreillumination sources and/or one or more lenses. The one or moreillumination sources may be directed to illuminate portions of thesurgical field. The one or more image sensors may receive lightreflected or refracted from the surgical field, including lightreflected or refracted from tissue and/or surgical instruments.

The one or more illumination sources may be configured to radiateelectromagnetic energy in the visible spectrum as well as the invisiblespectrum. The visible spectrum, sometimes referred to as the opticalspectrum or luminous spectrum, is that portion of the electromagneticspectrum that is visible to (i.e., can be detected by) the human eye andmay be referred to as visible light or simply light. A typical human eyewill respond to wavelengths in air that are from about 380 nm to about750 nm.

The invisible spectrum (i.e., the non-luminous spectrum) is that portionof the electromagnetic spectrum that lies below and above the visiblespectrum (i.e., wavelengths below about 380 nm and above about 750 nm).The invisible spectrum is not detectable by the human eye. Wavelengthsgreater than about 750 nm are longer than the red visible spectrum, andthey become invisible infrared (IR), microwave, and radioelectromagnetic radiation. Wavelengths less than about 380 nm areshorter than the violet spectrum, and they become invisible ultraviolet,x-ray, and gamma ray electromagnetic radiation.

In various aspects, the imaging device 124 is configured for use in aminimally invasive procedure. Examples of imaging devices suitable foruse with the present disclosure include, but not limited to, anarthroscope, angioscope, bronchoscope, choledochoscope, colonoscope,cytoscope, duodenoscope, enteroscope, esophagogastro-duodenoscope(gastroscope), endoscope, laryngoscope, nasopharyngo-neproscope,sigmoidoscope, thoracoscope, and ureteroscope.

In one aspect, the imaging device employs multi-spectrum monitoring todiscriminate topography and underlying structures. A multi-spectralimage is one that captures image data within specific wavelength rangesacross the electromagnetic spectrum. The wavelengths may be separated byfilters or by the use of instruments that are sensitive to particularwavelengths, including light from frequencies beyond the visible lightrange, e.g., IR and ultraviolet. Spectral imaging can allow extractionof additional information the human eye fails to capture with itsreceptors for red, green, and blue. The use of multi-spectral imaging isdescribed in greater detail under the heading “Advanced ImagingAcquisition Module” in U.S. Provisional Patent Application Ser. No.62/611,341, titled INTERACTIVE SURGICAL PLATFORM, filed Dec. 28, 2017,the disclosure of which is herein incorporated by reference in itsentirety. Multi-spectrum monitoring can be a useful tool in relocating asurgical field after a surgical task is completed to perform one or moreof the previously described tests on the treated tissue.

It is axiomatic that strict sterilization of the operating room andsurgical equipment is required during any surgery. The strict hygieneand sterilization conditions required in a “surgical theater,” i.e., anoperating or treatment room, necessitate the highest possible sterilityof all medical devices and equipment. Part of that sterilization processis the need to sterilize anything that comes in contact with the patientor penetrates the sterile field, including the imaging device 124 andits attachments and components. It will be appreciated that the sterilefield may be considered a specified area, such as within a tray or on asterile towel, that is considered free of microorganisms, or the sterilefield may be considered an area, immediately around a patient, who hasbeen prepared for a surgical procedure. The sterile field may includethe scrubbed team members, who are properly attired, and all furnitureand fixtures in the area.

In various aspects, the visualization system 108 includes one or moreimaging sensors, one or more image-processing units, one or more storagearrays, and one or more displays that are strategically arranged withrespect to the sterile field, as illustrated in FIG. 2. In one aspect,the visualization system 108 includes an interface for HL7, PACS, andEMR. Various components of the visualization system 108 are describedunder the heading “Advanced Imaging Acquisition Module” in U.S.Provisional Patent Application Ser. No. 62/611,341, titled INTERACTIVESURGICAL PLATFORM, filed Dec. 28, 2017, the disclosure of which isherein incorporated by reference in its entirety.

As illustrated in FIG. 2, a primary display 119 is positioned in thesterile field to be visible to an operator at the operating table 114.In addition, a visualization tower 111 is positioned outside the sterilefield. The visualization tower 111 includes a first non-sterile display107 and a second non-sterile display 109, which face away from eachother. The visualization system 108, guided by the hub 106, isconfigured to utilize the displays 107, 109, and 119 to coordinateinformation flow to operators inside and outside the sterile field. Forexample, the hub 106 may cause the visualization system 108 to display asnapshot of a surgical site, as recorded by an imaging device 124, on anon-sterile display 107 or 109, while maintaining a live feed of thesurgical site on the primary display 119. The snapshot on thenon-sterile display 107 or 109 can permit a non-sterile operator toperform a diagnostic step relevant to the surgical procedure, forexample.

In one aspect, the hub 106 is also configured to route a diagnosticinput or feedback entered by a non-sterile operator at the visualizationtower 111 to the primary display 119 within the sterile field, where itcan be viewed by a sterile operator at the operating table. In oneexample, the input can be in the form of a modification to the snapshotdisplayed on the non-sterile display 107 or 109, which can be routed tothe primary display 119 by the hub 106.

Referring to FIG. 2, a surgical instrument 112 is being used in thesurgical procedure as part of the surgical system 102. The hub 106 isalso configured to coordinate information flow to a display of thesurgical instrument 112. For example, coordinate information flow isfurther described in U.S. Provisional Patent Application Ser. No.62/611,341, titled INTERACTIVE SURGICAL PLATFORM, filed Dec. 28, 2017,the disclosure of which is herein incorporated by reference in itsentirety. A diagnostic input or feedback entered by a non-sterileoperator at the visualization tower 111 can be routed by the hub 106 tothe surgical instrument display 115 within the sterile field, where itcan be viewed by the operator of the surgical instrument 112. Examplesurgical instruments that are suitable for use with the surgical system102 are described under the heading “Surgical Instrument Hardware” inU.S. Provisional Patent Application Ser. No. 62/611,341, titledINTERACTIVE SURGICAL PLATFORM, filed Dec. 28, 2017, the disclosure ofwhich is herein incorporated by reference in its entirety, for example.

Referring now to FIG. 3, a hub 106 is depicted in communication with avisualization system 108, a robotic system 110, and a handheldintelligent surgical instrument 112. The hub 106 includes a hub display135, an imaging module 138, a generator module 140 (which can include amonopolar generator 142, a bipolar generator 144, and/or an ultrasonicgenerator 143), a communication module 130, a processor module 132, anda storage array 134. In certain aspects, as illustrated in FIG. 3, thehub 106 further includes a smoke evacuation module 126, asuction/irrigation module 128, and/or an OR mapping module 133.

During a surgical procedure, energy application to tissue, for sealingand/or cutting, is generally associated with smoke evacuation, suctionof excess fluid, and/or irrigation of the tissue. Fluid, power, and/ordata lines from different sources are often entangled during thesurgical procedure. Valuable time can be lost addressing this issueduring a surgical procedure. Detangling the lines may necessitatedisconnecting the lines from their respective modules, which may requireresetting the modules. The hub modular enclosure 136 offers a unifiedenvironment for managing the power, data, and fluid lines, which reducesthe frequency of entanglement between such lines.

Aspects of the present disclosure present a surgical hub for use in asurgical procedure that involves energy application to tissue at asurgical site. The surgical hub includes a hub enclosure and a combogenerator module slidably receivable in a docking station of the hubenclosure. The docking station includes data and power contacts. Thecombo generator module includes two or more of an ultrasonic energygenerator component, a bipolar RF energy generator component, and amonopolar RF energy generator component that are housed in a singleunit. In one aspect, the combo generator module also includes a smokeevacuation component, at least one energy delivery cable for connectingthe combo generator module to a surgical instrument, at least one smokeevacuation component configured to evacuate smoke, fluid, and/orparticulates generated by the application of therapeutic energy to thetissue, and a fluid line extending from the remote surgical site to thesmoke evacuation component.

In one aspect, the fluid line is a first fluid line and a second fluidline extends from the remote surgical site to a suction and irrigationmodule slidably received in the hub enclosure. In one aspect, the hubenclosure comprises a fluid interface.

Certain surgical procedures may require the application of more than oneenergy type to the tissue. One energy type may be more beneficial forcutting the tissue, while another different energy type may be morebeneficial for sealing the tissue. For example, a bipolar generator canbe used to seal the tissue while an ultrasonic generator can be used tocut the sealed tissue. Aspects of the present disclosure present asolution where a hub modular enclosure 136 is configured to accommodatedifferent generators, and facilitate an interactive communicationtherebetween. One of the advantages of the hub modular enclosure 136 isenabling the quick removal and/or replacement of various modules.

Aspects of the present disclosure present a modular surgical enclosurefor use in a surgical procedure that involves energy application totissue. The modular surgical enclosure includes a first energy-generatormodule, configured to generate a first energy for application to thetissue, and a first docking station comprising a first docking port thatincludes first data and power contacts, wherein the firstenergy-generator module is slidably movable into an electricalengagement with the power and data contacts and wherein the firstenergy-generator module is slidably movable out of the electricalengagement with the first power and data contacts.

Further to the above, the modular surgical enclosure also includes asecond energy-generator module configured to generate a second energy,different than the first energy, for application to the tissue, and asecond docking station comprising a second docking port that includessecond data and power contacts, wherein the second energy-generatormodule is slidably movable into an electrical engagement with the powerand data contacts, and wherein the second energy-generator module isslidably movable out of the electrical engagement with the second powerand data contacts.

In addition, the modular surgical enclosure also includes acommunication bus between the first docking port and the second dockingport, configured to facilitate communication between the firstenergy-generator module and the second energy-generator module.

Referring to FIGS. 3-7, aspects of the present disclosure are presentedfor a hub modular enclosure 136 that allows the modular integration of agenerator module 140, a smoke evacuation module 126, and asuction/irrigation module 128. The hub modular enclosure 136 furtherfacilitates interactive communication between the modules 140, 126, 128.As illustrated in FIG. 5, the generator module 140 can be a generatormodule with integrated monopolar, bipolar, and ultrasonic componentssupported in a single housing unit 139 slidably insertable into the hubmodular enclosure 136. As illustrated in FIG. 5, the generator module140 can be configured to connect to a monopolar device 146, a bipolardevice 147, and an ultrasonic device 148. Alternatively, the generatormodule 140 may comprise a series of monopolar, bipolar, and/orultrasonic generator modules that interact through the hub modularenclosure 136. The hub modular enclosure 136 can be configured tofacilitate the insertion of multiple generators and interactivecommunication between the generators docked into the hub modularenclosure 136 so that the generators would act as a single generator.

In one aspect, the hub modular enclosure 136 comprises a modular powerand communication backplane 149 with external and wireless communicationheaders to enable the removable attachment of the modules 140, 126, 128and interactive communication therebetween.

In one aspect, the hub modular enclosure 136 includes docking stations,or drawers, 151, herein also referred to as drawers, which areconfigured to slidably receive the modules 140, 126, 128. FIG. 4illustrates a partial perspective view of a surgical hub enclosure 136,and a combo generator module 145 slidably receivable in a dockingstation 151 of the surgical hub enclosure 136. A docking port 152 withpower and data contacts on a rear side of the combo generator module 145is configured to engage a corresponding docking port 150 with power anddata contacts of a corresponding docking station 151 of the hub modularenclosure 136 as the combo generator module 145 is slid into positionwithin the corresponding docking station 151 of the hub module enclosure136. In one aspect, the combo generator module 145 includes a bipolar,ultrasonic, and monopolar module and a smoke evacuation moduleintegrated together into a single housing unit 139, as illustrated inFIG. 5.

In various aspects, the smoke evacuation module 126 includes a fluidline 154 that conveys captured/collected smoke and/or fluid away from asurgical site and to, for example, the smoke evacuation module 126.Vacuum suction originating from the smoke evacuation module 126 can drawthe smoke into an opening of a utility conduit at the surgical site. Theutility conduit, coupled to the fluid line, can be in the form of aflexible tube terminating at the smoke evacuation module 126. Theutility conduit and the fluid line define a fluid path extending towardthe smoke evacuation module 126 that is received in the hub enclosure136.

In various aspects, the suction/irrigation module 128 is coupled to asurgical tool comprising an aspiration fluid line and a suction fluidline. In one example, the aspiration and suction fluid lines are in theform of flexible tubes extending from the surgical site toward thesuction/irrigation module 128. One or more drive systems can beconfigured to cause irrigation and aspiration of fluids to and from thesurgical site.

In one aspect, the surgical tool includes a shaft having an end effectorat a distal end thereof and at least one energy treatment associatedwith the end effector, an aspiration tube, and an irrigation tube. Theaspiration tube can have an inlet port at a distal end thereof and theaspiration tube extends through the shaft. Similarly, an irrigation tubecan extend through the shaft and can have an inlet port in proximity tothe energy deliver implement. The energy deliver implement is configuredto deliver ultrasonic and/or RF energy to the surgical site and iscoupled to the generator module 140 by a cable extending initiallythrough the shaft.

The irrigation tube can be in fluid communication with a fluid source,and the aspiration tube can be in fluid communication with a vacuumsource. The fluid source and/or the vacuum source can be housed in thesuction/irrigation module 128. In one example, the fluid source and/orthe vacuum source can be housed in the hub enclosure 136 separately fromthe suction/irrigation module 128. In such example, a fluid interfacecan be configured to connect the suction/irrigation module 128 to thefluid source and/or the vacuum source.

In one aspect, the modules 140, 126, 128 and/or their correspondingdocking stations on the hub modular enclosure 136 may include alignmentfeatures that are configured to align the docking ports of the modulesinto engagement with their counterparts in the docking stations of thehub modular enclosure 136. For example, as illustrated in FIG. 4, thecombo generator module 145 includes side brackets 155 that areconfigured to slidably engage with corresponding brackets 156 of thecorresponding docking station 151 of the hub modular enclosure 136. Thebrackets cooperate to guide the docking port contacts of the combogenerator module 145 into an electrical engagement with the docking portcontacts of the hub modular enclosure 136.

In some aspects, the drawers 151 of the hub modular enclosure 136 arethe same, or substantially the same size, and the modules are adjustedin size to be received in the drawers 151. For example, the sidebrackets 155 and/or 156 can be larger or smaller depending on the sizeof the module. In other aspects, the drawers 151 are different in sizeand are each designed to accommodate a particular module.

Furthermore, the contacts of a particular module can be keyed forengagement with the contacts of a particular drawer to avoid inserting amodule into a drawer with mismatching contacts.

As illustrated in FIG. 4, the docking port 150 of one drawer 151 can becoupled to the docking port 150 of another drawer 151 through acommunications link 157 to facilitate an interactive communicationbetween the modules housed in the hub modular enclosure 136. The dockingports 150 of the hub modular enclosure 136 may alternatively, oradditionally, facilitate a wireless interactive communication betweenthe modules housed in the hub modular enclosure 136. Any suitablewireless communication can be employed, such as for example AirTitan-Bluetooth.

FIG. 6 illustrates individual power bus attachments for a plurality oflateral docking ports of a lateral modular housing 160 configured toreceive a plurality of modules of a surgical hub 206. The lateralmodular housing 160 is configured to laterally receive and interconnectthe modules 161. The modules 161 are slidably inserted into dockingstations 162 of lateral modular housing 160, which includes a backplanefor interconnecting the modules 161. As illustrated in FIG. 6, themodules 161 are arranged laterally in the lateral modular housing 160.Alternatively, the modules 161 may be arranged vertically in a lateralmodular housing.

FIG. 7 illustrates a vertical modular housing 164 configured to receivea plurality of modules 165 of the surgical hub 106. The modules 165 areslidably inserted into docking stations, or drawers, 167 of verticalmodular housing 164, which includes a backplane for interconnecting themodules 165. Although the drawers 167 of the vertical modular housing164 are arranged vertically, in certain instances, a vertical modularhousing 164 may include drawers that are arranged laterally.Furthermore, the modules 165 may interact with one another through thedocking ports of the vertical modular housing 164. In the example ofFIG. 7, a display 177 is provided for displaying data relevant to theoperation of the modules 165. In addition, the vertical modular housing164 includes a master module 178 housing a plurality of sub-modules thatare slidably received in the master module 178.

In various aspects, the imaging module 138 comprises an integrated videoprocessor and a modular light source and is adapted for use with variousimaging devices. In one aspect, the imaging device is comprised of amodular housing that can be assembled with a light source module and acamera module. The housing can be a disposable housing. In at least oneexample, the disposable housing is removably coupled to a reusablecontroller, a light source module, and a camera module. The light sourcemodule and/or the camera module can be selectively chosen depending onthe type of surgical procedure. In one aspect, the camera modulecomprises a CCD sensor. In another aspect, the camera module comprises aCMOS sensor. In another aspect, the camera module is configured forscanned beam imaging. Likewise, the light source module can beconfigured to deliver a white light or a different light, depending onthe surgical procedure.

During a surgical procedure, removing a surgical device from thesurgical field and replacing it with another surgical device thatincludes a different camera or a different light source can beinefficient. Temporarily losing sight of the surgical field may lead toundesirable consequences. The module imaging device of the presentdisclosure is configured to permit the replacement of a light sourcemodule or a camera module midstream during a surgical procedure, withouthaving to remove the imaging device from the surgical field.

In one aspect, the imaging device comprises a tubular housing thatincludes a plurality of channels. A first channel is configured toslidably receive the camera module, which can be configured for asnap-fit engagement with the first channel. A second channel isconfigured to slidably receive the light source module, which can beconfigured for a snap-fit engagement with the second channel. In anotherexample, the camera module and/or the light source module can be rotatedinto a final position within their respective channels. A threadedengagement can be employed in lieu of the snap-fit engagement.

In various examples, multiple imaging devices are placed at differentpositions in the surgical field to provide multiple views. The imagingmodule 138 can be configured to switch between the imaging devices toprovide an optimal view. In various aspects, the imaging module 138 canbe configured to integrate the images from the different imaging device.

Various image processors and imaging devices suitable for use with thepresent disclosure are described in U.S. Pat. No. 7,995,045, titledCOMBINED SBI AND CONVENTIONAL IMAGE PROCESSOR, which issued on Aug. 9,2011, which is herein incorporated by reference in its entirety. Inaddition, U.S. Pat. No. 7,982,776, titled SBI MOTION ARTIFACT REMOVALAPPARATUS AND METHOD, which issued on Jul. 19, 2011, which is hereinincorporated by reference in its entirety, describes various systems forremoving motion artifacts from image data. Such systems can beintegrated with the imaging module 138. Furthermore, U.S. PatentApplication Publication No. 2011/0306840, titled CONTROLLABLE MAGNETICSOURCE TO FIXTURE INTRACORPOREAL APPARATUS, which published on Dec. 15,2011, and U.S. Patent Application Publication No. 2014/0243597, titledSYSTEM FOR PERFORMING A MINIMALLY INVASIVE SURGICAL PROCEDURE, whichpublished on Aug. 28, 2014, each of which is herein incorporated byreference in its entirety.

FIG. 8 illustrates a surgical data network 201 comprising a modularcommunication hub 203 configured to connect modular devices located inone or more operating theaters of a healthcare facility, or any room ina healthcare facility specially equipped for surgical operations, to acloud-based system (e.g., the cloud 204 that may include a remote server213 coupled to a storage device 205). In one aspect, the modularcommunication hub 203 comprises a network hub 207 and/or a networkswitch 209 in communication with a network router. The modularcommunication hub 203 also can be coupled to a local computer system 210to provide local computer processing and data manipulation. The surgicaldata network 201 may be configured as passive, intelligent, orswitching. A passive surgical data network serves as a conduit for thedata, enabling it to go from one device (or segment) to another and tothe cloud computing resources. An intelligent surgical data networkincludes additional features to enable the traffic passing through thesurgical data network to be monitored and to configure each port in thenetwork hub 207 or network switch 209. An intelligent surgical datanetwork may be referred to as a manageable hub or switch. A switchinghub reads the destination address of each packet and then forwards thepacket to the correct port.

Modular devices 1 a-1 n located in the operating theater may be coupledto the modular communication hub 203. The network hub 207 and/or thenetwork switch 209 may be coupled to a network router 211 to connect thedevices 1 a-1 n to the cloud 204 or the local computer system 210. Dataassociated with the devices 1 a-1 n may be transferred to cloud-basedcomputers via the router for remote data processing and manipulation.Data associated with the devices 1 a-1 n may also be transferred to thelocal computer system 210 for local data processing and manipulation.Modular devices 2 a-2 m located in the same operating theater also maybe coupled to a network switch 209. The network switch 209 may becoupled to the network hub 207 and/or the network router 211 to connectto the devices 2 a-2 m to the cloud 204. Data associated with thedevices 2 a-2 n may be transferred to the cloud 204 via the networkrouter 211 for data processing and manipulation. Data associated withthe devices 2 a-2 m may also be transferred to the local computer system210 for local data processing and manipulation.

It will be appreciated that the surgical data network 201 may beexpanded by interconnecting multiple network hubs 207 and/or multiplenetwork switches 209 with multiple network routers 211. The modularcommunication hub 203 may be contained in a modular control towerconfigured to receive multiple devices 1 a-1 n/2 a-2 m. The localcomputer system 210 also may be contained in a modular control tower.The modular communication hub 203 is connected to a display 212 todisplay images obtained by some of the devices 1 a-1 n/2 a-2 m, forexample during surgical procedures. In various aspects, the devices 1a-1 n/2 a-2 m may include, for example, various modules such as animaging module 138 coupled to an endoscope, a generator module 140coupled to an energy-based surgical device, a smoke evacuation module126, a suction/irrigation module 128, a communication module 130, aprocessor module 132, a storage array 134, a surgical device coupled toa display, and/or a non-contact sensor module, among other modulardevices that may be connected to the modular communication hub 203 ofthe surgical data network 201.

In one aspect, the surgical data network 201 may comprise a combinationof network hub(s), network switch(es), and network router(s) connectingthe devices 1 a-1 n/2 a-2 m to the cloud. Any one of or all of thedevices 1 a-1 n/2 a-2 m coupled to the network hub or network switch maycollect data in real time and transfer the data to cloud computers fordata processing and manipulation. It will be appreciated that cloudcomputing relies on sharing computing resources rather than having localservers or personal devices to handle software applications. The word“cloud” may be used as a metaphor for “the Internet,” although the termis not limited as such. Accordingly, the term “cloud computing” may beused herein to refer to “a type of Internet-based computing,” wheredifferent services—such as servers, storage, and applications—aredelivered to the modular communication hub 203 and/or computer system210 located in the surgical theater (e.g., a fixed, mobile, temporary,or field operating room or space) and to devices connected to themodular communication hub 203 and/or computer system 210 through theInternet. The cloud infrastructure may be maintained by a cloud serviceprovider. In this context, the cloud service provider may be the entitythat coordinates the usage and control of the devices 1 a-1 n/2 a-2 mlocated in one or more operating theaters. The cloud computing servicescan perform a large number of calculations based on the data gathered bysmart surgical instruments, robots, and other computerized deviceslocated in the operating theater. The hub hardware enables multipledevices or connections to be connected to a computer that communicateswith the cloud computing resources and storage.

Applying cloud computer data processing techniques on the data collectedby the devices 1 a-1 n/2 a-2 m, the surgical data network providesimproved surgical outcomes, reduced costs, and improved patientsatisfaction. At least some of the devices 1 a-1 n/2 a-2 m may beemployed to view tissue states to assess leaks or perfusion of sealedtissue after a tissue sealing and cutting procedure. At least some ofthe devices 1 a-1 n/2 a-2 m may be employed to identify pathology, suchas the effects of diseases, using the cloud-based computing to examinedata including images of samples of body tissue for diagnostic purposes.This includes localization and margin confirmation of tissue andphenotypes. At least some of the devices 1 a-1 n/2 a-2 m may be employedto identify anatomical structures of the body using a variety of sensorsintegrated with imaging devices and techniques such as overlaying imagescaptured by multiple imaging devices. The data gathered by the devices 1a-1 n/2 a-2 m, including image data, may be transferred to the cloud 204or the local computer system 210 or both for data processing andmanipulation including image processing and manipulation. The data maybe analyzed to improve surgical procedure outcomes by determining iffurther treatment, such as the application of endoscopic intervention,emerging technologies, a targeted radiation, targeted intervention, andprecise robotics to tissue-specific sites and conditions, may bepursued. Such data analysis may further employ outcome analyticsprocessing, and using standardized approaches may provide beneficialfeedback to either confirm surgical treatments and the behavior of thesurgeon or suggest modifications to surgical treatments and the behaviorof the surgeon.

In one implementation, the operating theater devices 1 a-1 n may beconnected to the modular communication hub 203 over a wired channel or awireless channel depending on the configuration of the devices 1 a-1 nto a network hub. The network hub 207 may be implemented, in one aspect,as a local network broadcast device that works on the physical layer ofthe Open System Interconnection (OSI) model. The network hub providesconnectivity to the devices 1 a-1 n located in the same operatingtheater network. The network hub 207 collects data in the form ofpackets and sends them to the router in half duplex mode. The networkhub 207 does not store any media access control/Internet Protocol(MAC/IP) to transfer the device data. Only one of the devices 1 a-1 ncan send data at a time through the network hub 207. The network hub 207has no routing tables or intelligence regarding where to sendinformation and broadcasts all network data across each connection andto a remote server 213 (FIG. 9) over the cloud 204. The network hub 207can detect basic network errors such as collisions, but having allinformation broadcast to multiple ports can be a security risk and causebottlenecks.

In another implementation, the operating theater devices 2 a-2 m may beconnected to a network switch 209 over a wired channel or a wirelesschannel. The network switch 209 works in the data link layer of the OSImodel. The network switch 209 is a multicast device for connecting thedevices 2 a-2 m located in the same operating theater to the network.The network switch 209 sends data in the form of frames to the networkrouter 211 and works in full duplex mode. Multiple devices 2 a-2 m cansend data at the same time through the network switch 209. The networkswitch 209 stores and uses MAC addresses of the devices 2 a-2 m totransfer data.

The network hub 207 and/or the network switch 209 are coupled to thenetwork router 211 for connection to the cloud 204. The network router211 works in the network layer of the OSI model. The network router 211creates a route for transmitting data packets received from the networkhub 207 and/or network switch 211 to cloud-based computer resources forfurther processing and manipulation of the data collected by any one ofor all the devices 1 a-1 n/2 a-2 m. The network router 211 may beemployed to connect two or more different networks located in differentlocations, such as, for example, different operating theaters of thesame healthcare facility or different networks located in differentoperating theaters of different healthcare facilities. The networkrouter 211 sends data in the form of packets to the cloud 204 and worksin full duplex mode. Multiple devices can send data at the same time.The network router 211 uses IP addresses to transfer data.

In one example, the network hub 207 may be implemented as a USB hub,which allows multiple USB devices to be connected to a host computer.The USB hub may expand a single USB port into several tiers so thatthere are more ports available to connect devices to the host systemcomputer. The network hub 207 may include wired or wireless capabilitiesto receive information over a wired channel or a wireless channel. Inone aspect, a wireless USB short-range, high-bandwidth wireless radiocommunication protocol may be employed for communication between thedevices 1 a-1 n and devices 2 a-2 m located in the operating theater.

In other examples, the operating theater devices 1 a-1 n/2 a-2 m maycommunicate to the modular communication hub 203 via Bluetooth wirelesstechnology standard for exchanging data over short distances (usingshort-wavelength UHF radio waves in the ISM band from 2.4 to 2.485 GHz)from fixed and mobile devices and building personal area networks(PANs). In other aspects, the operating theater devices 1 a-1 n/2 a-2 mmay communicate to the modular communication hub 203 via a number ofwireless or wired communication standards or protocols, including butnot limited to W-Fi (IEEE 802.11 family), WiMAX (IEEE 802.16 family),IEEE 802.20, long-term evolution (LTE), and Ev-DO, HSPA+, HSDPA+,HSUPA+, EDGE, GSM, GPRS, CDMA, TDMA, DECT, and Ethernet derivativesthereof, as well as any other wireless and wired protocols that aredesignated as 3G, 4G, 5G, and beyond. The computing module may include aplurality of communication modules. For instance, a first communicationmodule may be dedicated to shorter-range wireless communications such asWi-Fi and Bluetooth, and a second communication module may be dedicatedto longer-range wireless communications such as GPS, EDGE, GPRS, CDMA,WiMAX, LTE, Ev-DO, and others.

The modular communication hub 203 may serve as a central connection forone or all of the operating theater devices 1 a-1 n/2 a-2 m and handlesa data type known as frames. Frames carry the data generated by thedevices 1 a-1 n/2 a-2 m. When a frame is received by the modularcommunication hub 203, it is amplified and transmitted to the networkrouter 211, which transfers the data to the cloud computing resources byusing a number of wireless or wired communication standards orprotocols, as described herein.

The modular communication hub 203 can be used as a standalone device orbe connected to compatible network hubs and network switches to form alarger network. The modular communication hub 203 is generally easy toinstall, configure, and maintain, making it a good option for networkingthe operating theater devices 1 a-1 n/2 a-2 m.

FIG. 9 illustrates a computer-implemented interactive surgical system200. The computer-implemented interactive surgical system 200 is similarin many respects to the computer-implemented interactive surgical system100. For example, the computer-implemented interactive surgical system200 includes one or more surgical systems 202, which are similar in manyrespects to the surgical systems 102. Each surgical system 202 includesat least one surgical hub 206 in communication with a cloud 204 that mayinclude a remote server 213. In one aspect, the computer-implementedinteractive surgical system 200 comprises a modular control tower 236connected to multiple operating theater devices such as, for example,intelligent surgical instruments, robots, and other computerized deviceslocated in the operating theater. As shown in FIG. 10, the modularcontrol tower 236 comprises a modular communication hub 203 coupled to acomputer system 210. As illustrated in the example of FIG. 9, themodular control tower 236 is coupled to an imaging module 238 that iscoupled to an endoscope 239, a generator module 240 that is coupled toan energy device 241, a smoke evacuator module 226, a suction/irrigationmodule 228, a communication module 230, a processor module 232, astorage array 234, a smart device/instrument 235 optionally coupled to adisplay 237, and a non-contact sensor module 242. The operating theaterdevices are coupled to cloud computing resources and data storage viathe modular control tower 236. A robot hub 222 also may be connected tothe modular control tower 236 and to the cloud computing resources. Thedevices/instruments 235, visualization systems 208, among others, may becoupled to the modular control tower 236 via wired or wirelesscommunication standards or protocols, as described herein. The modularcontrol tower 236 may be coupled to a hub display 215 (e.g., monitor,screen) to display and overlay images received from the imaging module,device/instrument display, and/or other visualization systems 208. Thehub display also may display data received from devices connected to themodular control tower in conjunction with images and overlaid images.

FIG. 10 illustrates a surgical hub 206 comprising a plurality of modulescoupled to the modular control tower 236. The modular control tower 236comprises a modular communication hub 203, e.g., a network connectivitydevice, and a computer system 210 to provide local processing,visualization, and imaging, for example. As shown in FIG. 10, themodular communication hub 203 may be connected in a tiered configurationto expand the number of modules (e.g., devices) that may be connected tothe modular communication hub 203 and transfer data associated with themodules to the computer system 210, cloud computing resources, or both.As shown in FIG. 10, each of the network hubs/switches in the modularcommunication hub 203 includes three downstream ports and one upstreamport. The upstream network hub/switch is connected to a processor toprovide a communication connection to the cloud computing resources anda local display 217. Communication to the cloud 204 may be made eitherthrough a wired or a wireless communication channel.

The surgical hub 206 employs a non-contact sensor module 242 to measurethe dimensions of the operating theater and generate a map of thesurgical theater using either ultrasonic or laser-type non-contactmeasurement devices. An ultrasound-based non-contact sensor module scansthe operating theater by transmitting a burst of ultrasound andreceiving the echo when it bounces off the perimeter walls of anoperating theater as described under the heading “Surgical Hub SpatialAwareness Within an Operating Room” in U.S. Provisional PatentApplication Ser. No. 62/611,341, titled INTERACTIVE SURGICAL PLATFORM,filed Dec. 28, 2017, which is herein incorporated by reference in itsentirety, in which the sensor module is configured to determine the sizeof the operating theater and to adjust Bluetooth-pairing distancelimits. A laser-based non-contact sensor module scans the operatingtheater by transmitting laser light pulses, receiving laser light pulsesthat bounce off the perimeter walls of the operating theater, andcomparing the phase of the transmitted pulse to the received pulse todetermine the size of the operating theater and to adjust Bluetoothpairing distance limits, for example.

The computer system 210 comprises a processor 244 and a networkinterface 245. The processor 244 is coupled to a communication module247, storage 248, memory 249, non-volatile memory 250, and input/outputinterface 251 via a system bus. The system bus can be any of severaltypes of bus structure(s) including the memory bus or memory controller,a peripheral bus or external bus, and/or a local bus using any varietyof available bus architectures including, but not limited to, 9-bit bus,Industrial Standard Architecture (ISA), Micro-Charmel Architecture(MSA), Extended ISA (EISA), Intelligent Drive Electronics (IDE), VESALocal Bus (VLB), Peripheral Component Interconnect (PCI), USB, AdvancedGraphics Port (AGP), Personal Computer Memory Card InternationalAssociation bus (PCMCIA), Small Computer Systems Interface (SCSI), orany other proprietary bus.

The processor 244 may be any single-core or multicore processor such asthose known under the trade name ARM Cortex by Texas Instruments. In oneaspect, the processor may be an LM4F230H5QR ARM Cortex-M4F ProcessorCore, available from Texas Instruments, for example, comprising anon-chip memory of 256 KB single-cycle flash memory, or othernon-volatile memory, up to 40 MHz, a prefetch buffer to improveperformance above 40 MHz, a 32 KB single-cycle serial random accessmemory (SRAM), an internal read-only memory (ROM) loaded withStellarisWare® software, a 2 KB electrically erasable programmableread-only memory (EEPROM), and/or one or more pulse width modulation(PWM) modules, one or more quadrature encoder inputs (QEI) analogs, oneor more 12-bit analog-to-digital converters (ADCs) with 12 analog inputchannels, details of which are available for the product datasheet.

In one aspect, the processor 244 may comprise a safety controllercomprising two controller-based families such as TMS570 and RM4x, knownunder the trade name Hercules ARM Cortex R4, also by Texas Instruments.The safety controller may be configured specifically for IEC 61508 andISO 26262 safety critical applications, among others, to provideadvanced integrated safety features while delivering scalableperformance, connectivity, and memory options.

The system memory includes volatile memory and non-volatile memory. Thebasic input/output system (BIOS), containing the basic routines totransfer information between elements within the computer system, suchas during start-up, is stored in non-volatile memory. For example, thenon-volatile memory can include ROM, programmable ROM (PROM),electrically programmable ROM (EPROM), EEPROM, or flash memory. Volatilememory includes random-access memory (RAM), which acts as external cachememory. Moreover, RAM is available in many forms such as SRAM, dynamicRAM (DRAM), synchronous DRAM (SDRAM), double data rate SDRAM (DDRSDRAM), enhanced SDRAM (ESDRAM), Synchlink DRAM (SLDRAM), and directRambus RAM (DRRAM).

The computer system 210 also includes removable/non-removable,volatile/non-volatile computer storage media, such as for example diskstorage. The disk storage includes, but is not limited to, devices likea magnetic disk drive, floppy disk drive, tape drive, Jaz drive, Zipdrive, LS-60 drive, flash memory card, or memory stick. In addition, thedisk storage can include storage media separately or in combination withother storage media including, but not limited to, an optical disc drivesuch as a compact disc ROM device (CD-ROM), compact disc recordabledrive (CD-R Drive), compact disc rewritable drive (CD-RW Drive), or adigital versatile disc ROM drive (DVD-ROM). To facilitate the connectionof the disk storage devices to the system bus, a removable ornon-removable interface may be employed.

It is to be appreciated that the computer system 210 includes softwarethat acts as an intermediary between users and the basic computerresources described in a suitable operating environment. Such softwareincludes an operating system. The operating system, which can be storedon the disk storage, acts to control and allocate resources of thecomputer system. System applications take advantage of the management ofresources by the operating system through program modules and programdata stored either in the system memory or on the disk storage. It is tobe appreciated that various components described herein can beimplemented with various operating systems or combinations of operatingsystems.

A user enters commands or information into the computer system 210through input device(s) coupled to the I/O interface 251. The inputdevices include, but are not limited to, a pointing device such as amouse, trackball, stylus, touch pad, keyboard, microphone, joystick,game pad, satellite dish, scanner, TV tuner card, digital camera,digital video camera, web camera, and the like. These and other inputdevices connect to the processor through the system bus via interfaceport(s). The interface port(s) include, for example, a serial port, aparallel port, a game port, and a USB. The output device(s) use some ofthe same types of ports as input device(s). Thus, for example, a USBport may be used to provide input to the computer system and to outputinformation from the computer system to an output device. An outputadapter is provided to illustrate that there are some output deviceslike monitors, displays, speakers, and printers, among other outputdevices that require special adapters. The output adapters include, byway of illustration and not limitation, video and sound cards thatprovide a means of connection between the output device and the systembus. It should be noted that other devices and/or systems of devices,such as remote computer(s), provide both input and output capabilities.

The computer system 210 can operate in a networked environment usinglogical connections to one or more remote computers, such as cloudcomputer(s), or local computers. The remote cloud computer(s) can be apersonal computer, server, router, network PC, workstation,microprocessor-based appliance, peer device, or other common networknode, and the like, and typically includes many or all of the elementsdescribed relative to the computer system. For purposes of brevity, onlya memory storage device is illustrated with the remote computer(s). Theremote computer(s) is logically connected to the computer system througha network interface and then physically connected via a communicationconnection. The network interface encompasses communication networkssuch as local area networks (LANs) and wide area networks (WANs). LANtechnologies include Fiber Distributed Data Interface (FDDI), CopperDistributed Data Interface (CDDI), Ethernet/IEEE 802.3, Token Ring/IEEE802.5 and the like. WAN technologies include, but are not limited to,point-to-point links, circuit-switching networks like IntegratedServices Digital Networks (ISDN) and variations thereon,packet-switching networks, and Digital Subscriber Lines (DSL).

In various aspects, the computer system 210 of FIG. 10, the imagingmodule 238 and/or visualization system 208, and/or the processor module232 of FIGS. 9-10, may comprise an image processor, image-processingengine, media processor, or any specialized digital signal processor(DSP) used for the processing of digital images. The image processor mayemploy parallel computing with single instruction, multiple data (SIMD)or multiple instruction, multiple data (MIMD) technologies to increasespeed and efficiency. The digital image-processing engine can perform arange of tasks. The image processor may be a system on a chip withmulticore processor architecture.

The communication connection(s) refers to the hardware/software employedto connect the network interface to the bus. While the communicationconnection is shown for illustrative clarity inside the computer system,it can also be external to the computer system 210. Thehardware/software necessary for connection to the network interfaceincludes, for illustrative purposes only, internal and externaltechnologies such as modems, including regular telephone-grade modems,cable modems, and DSL modems, ISDN adapters, and Ethernet cards.

In various aspects, the devices/instruments 235 described with referenceto FIGS. 9-10, may be implemented as ultrasonic surgical instruments andcombination energy surgical instruments 7012 as described in FIGS.23A-23B, 24A-24B, 25-26, 27A-27C, 28A-28C, 29A-29C, 30A-30D, 31A-31D,32A-32E. Accordingly, the ultrasonic/combination surgical instrument7012 as described in FIGS. 23A-23B, 24A-24B, 25-26, 27A-27C, 28A-28C,29A-29C, 30A-30D, 31A-31D, 32A-32E is configured to interface with themodular control tower 236 and the surgical hub 206. Once connected tothe surgical hub 206, the ultrasonic/combination surgical instrument7012 as described in FIGS. 23A-23B, 24A-24B, 25-26, 27A-27C, 28A-28C,29A-29C, 30A-30D, 31A-31D, 32A-32E is configured to interface with thecloud 204, the server 213, other hub connected instruments, the hubdisplay 215, or the visualization system 209, or combinations thereof.Further, once connected to hub 206, the ultrasonic/combination surgicalinstrument 7012 as described in FIGS. 23A-23B, 24A-24B, 25-26, 27A-27C,28A-28C, 29A-29C, 30A-30D, 31A-31D, 32A-32E may utilize the processingcircuits available in the hub local computer system 210.

FIG. 11 illustrates a functional block diagram of one aspect of a USBnetwork hub 300 device, in accordance with at least one aspect of thepresent disclosure. In the illustrated aspect, the USB network hubdevice 300 employs a TUSB2036 integrated circuit hub by TexasInstruments. The USB network hub 300 is a CMOS device that provides anupstream USB transceiver port 302 and up to three downstream USBtransceiver ports 304, 306, 308 in compliance with the USB 2.0specification. The upstream USB transceiver port 302 is a differentialroot data port comprising a differential data minus (DM0) input pairedwith a differential data plus (DP0) input. The three downstream USBtransceiver ports 304, 306, 308 are differential data ports where eachport includes differential data plus (DP1-DP3) outputs paired withdifferential data minus (DM1-DM3) outputs.

The USB network hub 300 device is implemented with a digital statemachine instead of a microcontroller, and no firmware programming isrequired. Fully compliant USB transceivers are integrated into thecircuit for the upstream USB transceiver port 302 and all downstream USBtransceiver ports 304, 306, 308. The downstream USB transceiver ports304, 306, 308 support both full-speed and low-speed devices byautomatically setting the slew rate according to the speed of the deviceattached to the ports. The USB network hub 300 device may be configuredeither in bus-powered or self-powered mode and includes a hub powerlogic 312 to manage power.

The USB network hub 300 device includes a serial interface engine 310(SIE). The SIE 310 is the front end of the USB network hub 300 hardwareand handles most of the protocol described in chapter 8 of the USBspecification. The SIE 310 typically comprehends signaling up to thetransaction level. The functions that it handles could include: packetrecognition, transaction sequencing, SOP, EOP, RESET, and RESUME signaldetection/generation, clock/data separation, non-return-to-zero invert(NRZI) data encoding/decoding and bit-stuffing, CRC generation andchecking (token and data), packet ID (PID) generation andchecking/decoding, and/or serial-parallel/parallel-serial conversion.The 310 receives a clock input 314 and is coupled to a suspend/resumelogic and frame timer 316 circuit and a hub repeater circuit 318 tocontrol communication between the upstream USB transceiver port 302 andthe downstream USB transceiver ports 304, 306, 308 through port logiccircuits 320, 322, 324. The SIE 310 is coupled to a command decoder 326via interface logic 328 to control commands from a serial EEPROM via aserial EEPROM interface 330.

In various aspects, the USB network hub 300 can connect 127 functionsconfigured in up to six logical layers (tiers) to a single computer.Further, the USB network hub 300 can connect to all peripherals using astandardized four-wire cable that provides both communication and powerdistribution. The power configurations are bus-powered and self-poweredmodes. The USB network hub 300 may be configured to support four modesof power management: a bus-powered hub, with either individual-portpower management or ganged-port power management, and the self-poweredhub, with either individual-port power management or ganged-port powermanagement. In one aspect, using a USB cable, the USB network hub 300,the upstream USB transceiver port 302 is plugged into a USB hostcontroller, and the downstream USB transceiver ports 304, 306, 308 areexposed for connecting USB compatible devices, and so forth.

Additional details regarding the structure and function of the surgicalhub and/or surgical hub networks can be found in U.S. Provisional PatentApplication No. 62/659,900, titled METHOD OF HUB COMMUNICATION, filedApr. 19, 2018, which is hereby incorporated by reference herein in itsentirety.

Cloud System Hardware and Functional Modules

FIG. 12 is a block diagram of the computer-implemented interactivesurgical system, in accordance with at least one aspect of the presentdisclosure. In one aspect, the computer-implemented interactive surgicalsystem is configured to monitor and analyze data related to theoperation of various surgical systems that include surgical hubs,surgical instruments, robotic devices and operating theaters orhealthcare facilities. The computer-implemented interactive surgicalsystem comprises a cloud-based analytics system. Although thecloud-based analytics system is described as a surgical system, it isnot necessarily limited as such and could be a cloud-based medicalsystem generally. As illustrated in FIG. 12, the cloud-based analyticssystem comprises a plurality of surgical instruments 7012 (may be thesame or similar to instruments 112), a plurality of surgical hubs 7006(may be the same or similar to hubs 106), and a surgical data network7001 (may be the same or similar to network 201) to couple the surgicalhubs 7006 to the cloud 7004 (may be the same or similar to cloud 204).Each of the plurality of surgical hubs 7006 is communicatively coupledto one or more surgical instruments 7012. The hubs 7006 are alsocommunicatively coupled to the cloud 7004 of the computer-implementedinteractive surgical system via the network 7001. The cloud 7004 is aremote centralized source of hardware and software for storing,manipulating, and communicating data generated based on the operation ofvarious surgical systems. As shown in FIG. 12, access to the cloud 7004is achieved via the network 7001, which may be the Internet or someother suitable computer network. Surgical hubs 7006 that are coupled tothe cloud 7004 can be considered the client side of the cloud computingsystem (i.e., cloud-based analytics system). Surgical instruments 7012are paired with the surgical hubs 7006 for control and implementation ofvarious surgical procedures or operations as described herein.

In addition, surgical instruments 7012 may comprise transceivers fordata transmission to and from their corresponding surgical hubs 7006(which may also comprise transceivers). Combinations of surgicalinstruments 7012 and corresponding hubs 7006 may indicate particularlocations, such as operating theaters in healthcare facilities (e.g.,hospitals), for providing medical operations. For example, the memory ofa surgical hub 7006 may store location data. As shown in FIG. 12, thecloud 7004 comprises central servers 7013 (which may be same or similarto remote server 113 in FIG. 1 and/or remote server 213 in FIG. 9), hubapplication servers 7002, data analytics modules 7034, and aninput/output (“I/O”) interface 7007. The central servers 7013 of thecloud 7004 collectively administer the cloud computing system, whichincludes monitoring requests by client surgical hubs 7006 and managingthe processing capacity of the cloud 7004 for executing the requests.Each of the central servers 7013 comprises one or more processors 7008coupled to suitable memory devices 7010 which can include volatilememory such as random-access memory (RAM) and non-volatile memory suchas magnetic storage devices. The memory devices 7010 may comprisemachine executable instructions that when executed cause the processors7008 to execute the data analytics modules 7034 for the cloud-based dataanalysis, operations, recommendations and other operations describedbelow. Moreover, the processors 7008 can execute the data analyticsmodules 7034 independently or in conjunction with hub applicationsindependently executed by the hubs 7006. The central servers 7013 alsocomprise aggregated medical data databases 2212, which can reside in thememory 2210.

Based on connections to various surgical hubs 7006 via the network 7001,the cloud 7004 can aggregate data from specific data generated byvarious surgical instruments 7012 and their corresponding hubs 7006.Such aggregated data may be stored within the aggregated medicaldatabases 7011 of the cloud 7004. In particular, the cloud 7004 mayadvantageously perform data analysis and operations on the aggregateddata to yield insights and/or perform functions that individual hubs7006 could not achieve on their own. To this end, as shown in FIG. 12,the cloud 7004 and the surgical hubs 7006 are communicatively coupled totransmit and receive information. The I/O interface 7007 is connected tothe plurality of surgical hubs 7006 via the network 7001. In this way,the I/O interface 7007 can be configured to transfer information betweenthe surgical hubs 7006 and the aggregated medical data databases 7011.Accordingly, the I/O interface 7007 may facilitate read/write operationsof the cloud-based analytics system. Such read/write operations may beexecuted in response to requests from hubs 7006. These requests could betransmitted to the hubs 7006 through the hub applications. The I/Ointerface 7007 may include one or more high speed data ports, which mayinclude universal serial bus (USB) ports, IEEE 1394 ports, as well asW-Fi and Bluetooth I/O interfaces for connecting the cloud 7004 to hubs7006. The hub application servers 7002 of the cloud 7004 are configuredto host and supply shared capabilities to software applications (e.g.hub applications) executed by surgical hubs 7006. For example, the hubapplication servers 7002 may manage requests made by the hubapplications through the hubs 7006, control access to the aggregatedmedical data databases 7011, and perform load balancing. The dataanalytics modules 7034 are described in further detail with reference toFIG. 13.

The particular cloud computing system configuration described in thepresent disclosure is specifically designed to address various issuesarising in the context of medical operations and procedures performedusing medical devices, such as the surgical instruments 7012, 112. Inparticular, the surgical instruments 7012 may be digital surgicaldevices configured to interact with the cloud 7004 for implementingtechniques to improve the performance of surgical operations. Varioussurgical instruments 7012 and/or surgical hubs 7006 may comprise touchcontrolled user interfaces such that clinicians may control aspects ofinteraction between the surgical instruments 7012 and the cloud 7004.Other suitable user interfaces for control such as auditory controlleduser interfaces can also be used.

FIG. 13 is a block diagram which illustrates the functional architectureof the computer-implemented interactive surgical system, in accordancewith at least one aspect of the present disclosure. The cloud-basedanalytics system includes a plurality of data analytics modules 7034that may be executed by the processors 7008 of the cloud 7004 forproviding data analytic solutions to problems specifically arising inthe medical field. As shown in FIG. 13, the functions of the cloud-baseddata analytics modules 7034 may be assisted via hub applications 7014hosted by the hub application servers 7002 that may be accessed onsurgical hubs 7006. The cloud processors 7008 and hub applications 7014may operate in conjunction to execute the data analytics modules 7034.Application program interfaces (APIs) 7016 define the set of protocolsand routines corresponding to the hub applications 7014. Additionally,the APIs 7016 manage the storing and retrieval of data into and from theaggregated medical data databases 7011 for the operations of theapplications 7014. The caches 7018 also store data (e.g., temporarily)and are coupled to the APIs 7016 for more efficient retrieval of dataused by the applications 7014. The data analytics modules 7034 in FIG.13 include modules for resource optimization 7020, data collection andaggregation 7022, authorization and security 7024, control programupdating 7026, patient outcome analysis 7028, recommendations 7030, anddata sorting and prioritization 7032. Other suitable data analyticsmodules could also be implemented by the cloud 7004, according to someaspects. In one aspect, the data analytics modules are used for specificrecommendations based on analyzing trends, outcomes, and other data.

For example, the data collection and aggregation module 7022 could beused to generate self-describing data (e.g., metadata) includingidentification of notable features or configuration (e.g., trends),management of redundant data sets, and storage of the data in paireddata sets which can be grouped by surgery but not necessarily keyed toactual surgical dates and surgeons. In particular, pair data setsgenerated from operations of surgical instruments 7012 can compriseapplying a binary classification, e.g., a bleeding or a non-bleedingevent. More generally, the binary classification may be characterized aseither a desirable event (e.g., a successful surgical procedure) or anundesirable event (e.g., a misfired or misused surgical instrument7012). The aggregated self-describing data may correspond to individualdata received from various groups or subgroups of surgical hubs 7006.Accordingly, the data collection and aggregation module 7022 cangenerate aggregated metadata or other organized data based on raw datareceived from the surgical hubs 7006. To this end, the processors 7008can be operationally coupled to the hub applications 7014 and aggregatedmedical data databases 7011 for executing the data analytics modules7034. The data collection and aggregation module 7022 may store theaggregated organized data into the aggregated medical data databases2212.

The resource optimization module 7020 can be configured to analyze thisaggregated data to determine an optimal usage of resources for aparticular or group of healthcare facilities. For example, the resourceoptimization module 7020 may determine an optimal order point ofsurgical stapling instruments 7012 for a group of healthcare facilitiesbased on corresponding predicted demand of such instruments 7012. Theresource optimization module 7020 might also assess the resource usageor other operational configurations of various healthcare facilities todetermine whether resource usage could be improved. Similarly, therecommendations module 7030 can be configured to analyze aggregatedorganized data from the data collection and aggregation module 7022 toprovide recommendations. For example, the recommendations module 7030could recommend to healthcare facilities (e.g., medical serviceproviders such as hospitals) that a particular surgical instrument 7012should be upgraded to an improved version based on a higher thanexpected error rate, for example. Additionally, the recommendationsmodule 7030 and/or resource optimization module 7020 could recommendbetter supply chain parameters such as product reorder points andprovide suggestions of different surgical instrument 7012, uses thereof,or procedure steps to improve surgical outcomes. The healthcarefacilities can receive such recommendations via corresponding surgicalhubs 7006. More specific recommendations regarding parameters orconfigurations of various surgical instruments 7012 can also beprovided. Hubs 7006 and/or surgical instruments 7012 each could alsohave display screens that display data or recommendations provided bythe cloud 7004.

The patient outcome analysis module 7028 can analyze surgical outcomesassociated with currently used operational parameters of surgicalinstruments 7012. The patient outcome analysis module 7028 may alsoanalyze and assess other potential operational parameters. In thisconnection, the recommendations module 7030 could recommend using theseother potential operational parameters based on yielding better surgicaloutcomes, such as better sealing or less bleeding. For example, therecommendations module 7030 could transmit recommendations to a surgicalhub 7006 regarding when to use a particular cartridge for acorresponding stapling surgical instrument 7012. Thus, the cloud-basedanalytics system, while controlling for common variables, may beconfigured to analyze the large collection of raw data and to providecentralized recommendations over multiple healthcare facilities(advantageously determined based on aggregated data). For example, thecloud-based analytics system could analyze, evaluate, and/or aggregatedata based on type of medical practice, type of patient, number ofpatients, geographic similarity between medical providers, which medicalproviders/facilities use similar types of instruments, etc., in a waythat no single healthcare facility alone would be able to analyzeindependently.

The control program updating module 7026 could be configured toimplement various surgical instrument 7012 recommendations whencorresponding control programs are updated. For example, the patientoutcome analysis module 7028 could identify correlations linkingspecific control parameters with successful (or unsuccessful) results.Such correlations may be addressed when updated control programs aretransmitted to surgical instruments 7012 via the control programupdating module 7026. Updates to instruments 7012 that are transmittedvia a corresponding hub 7006 may incorporate aggregated performance datathat was gathered and analyzed by the data collection and aggregationmodule 7022 of the cloud 7004. Additionally, the patient outcomeanalysis module 7028 and recommendations module 7030 could identifyimproved methods of using instruments 7012 based on aggregatedperformance data.

The cloud-based analytics system may include security featuresimplemented by the cloud 7004. These security features may be managed bythe authorization and security module 7024. Each surgical hub 7006 canhave associated unique credentials such as username, password, and othersuitable security credentials. These credentials could be stored in thememory 7010 and be associated with a permitted cloud access level. Forexample, based on providing accurate credentials, a surgical hub 7006may be granted access to communicate with the cloud to a predeterminedextent (e.g., may only engage in transmitting or receiving certaindefined types of information). To this end, the aggregated medical datadatabases 7011 of the cloud 7004 may comprise a database of authorizedcredentials for verifying the accuracy of provided credentials.Different credentials may be associated with varying levels ofpermission for interaction with the cloud 7004, such as a predeterminedaccess level for receiving the data analytics generated by the cloud7004.

Furthermore, for security purposes, the cloud could maintain a databaseof hubs 7006, instruments 7012, and other devices that may comprise a“black list” of prohibited devices. In particular, a surgical hub 7006listed on the black list may not be permitted to interact with thecloud, while surgical instruments 7012 listed on the black list may nothave functional access to a corresponding hub 7006 and/or may beprevented from fully functioning when paired to its corresponding hub7006. Additionally or alternatively, the cloud 7004 may flag instruments7012 based on incompatibility or other specified criteria. In thismanner, counterfeit medical devices and improper reuse of such devicesthroughout the cloud-based analytics system can be identified andaddressed.

The surgical instruments 7012 may use wireless transceivers to transmitwireless signals that may represent, for example, authorizationcredentials for access to corresponding hubs 7006 and the cloud 7004.Wired transceivers may also be used to transmit signals. Suchauthorization credentials can be stored in the respective memory devicesof the surgical instruments 7012. The authorization and security module7024 can determine whether the authorization credentials are accurate orcounterfeit. The authorization and security module 7024 may alsodynamically generate authorization credentials for enhanced security.The credentials could also be encrypted, such as by using hash basedencryption. Upon transmitting proper authorization, the surgicalinstruments 7012 may transmit a signal to the corresponding hubs 7006and ultimately the cloud 7004 to indicate that the instruments 7012 areready to obtain and transmit medical data. In response, the cloud 7004may transition into a state enabled for receiving medical data forstorage into the aggregated medical data databases 7011. This datatransmission readiness could be indicated by a light indicator on theinstruments 7012, for example. The cloud 7004 can also transmit signalsto surgical instruments 7012 for updating their associated controlprograms. The cloud 7004 can transmit signals that are directed to aparticular class of surgical instruments 7012 (e.g., electrosurgicalinstruments) so that software updates to control programs are onlytransmitted to the appropriate surgical instruments 7012. Moreover, thecloud 7004 could be used to implement system wide solutions to addresslocal or global problems based on selective data transmission andauthorization credentials. For example, if a group of surgicalinstruments 7012 are identified as having a common manufacturing defect,the cloud 7004 may change the authorization credentials corresponding tothis group to implement an operational lockout of the group.

The cloud-based analytics system may allow for monitoring multiplehealthcare facilities (e.g., medical facilities like hospitals) todetermine improved practices and recommend changes (via therecommendations module 2030, for example) accordingly. Thus, theprocessors 7008 of the cloud 7004 can analyze data associated with anindividual healthcare facility to identify the facility and aggregatethe data with other data associated with other healthcare facilities ina group. Groups could be defined based on similar operating practices orgeographical location, for example. In this way, the cloud 7004 mayprovide healthcare facility group wide analysis and recommendations. Thecloud-based analytics system could also be used for enhanced situationalawareness. For example, the processors 7008 may predictively model theeffects of recommendations on the cost and effectiveness for aparticular facility (relative to overall operations and/or variousmedical procedures). The cost and effectiveness associated with thatparticular facility can also be compared to a corresponding local regionof other facilities or any other comparable facilities.

The data sorting and prioritization module 7032 may prioritize and sortdata based on criticality (e.g., the severity of a medical eventassociated with the data, unexpectedness, suspiciousness). This sortingand prioritization may be used in conjunction with the functions of theother data analytics modules 7034 described above to improve thecloud-based analytics and operations described herein. For example, thedata sorting and prioritization module 7032 can assign a priority to thedata analysis performed by the data collection and aggregation module7022 and patient outcome analysis modules 7028. Different prioritizationlevels can result in particular responses from the cloud 7004(corresponding to a level of urgency) such as escalation for anexpedited response, special processing, exclusion from the aggregatedmedical data databases 7011, or other suitable responses. Moreover, ifnecessary, the cloud 7004 can transmit a request (e.g. a push message)through the hub application servers for additional data fromcorresponding surgical instruments 7012. The push message can result ina notification displayed on the corresponding hubs 7006 for requestingsupporting or additional data. This push message may be required insituations in which the cloud detects a significant irregularity oroutlier and the cloud cannot determine the cause of the irregularity.The central servers 7013 may be programmed to trigger this push messagein certain significant circumstances, such as when data is determined tobe different from an expected value beyond a predetermined threshold orwhen it appears security has been comprised, for example.

In various aspects, the surgical instrument(s) 7012 described above withreference to FIGS. 12 and 13, may be implemented as ultrasonic surgicalinstruments and combination energy surgical instruments 7012 asdescribed in FIGS. 23A-23B, 24A-24B, 25-26, 27A-27C, 28A-28C, 29A-29C,30A-30D, 31A-31D, 32A-32E. Accordingly, the as ultrasonic surgicalinstrument and combination energy surgical instrument 7012 as describedin FIGS. 23A-23B, 24A-24B, 25-26, 27A-27C, 28A-28C, 29A-29C, 30A-30D,31A-31D, 32A-32E is configured to interface with the surgical hub 7006and the network 2001, which is configured to interface with cloud 7004.Accordingly, the processing power provided by the central servers 7013and the data analytics module 7034 are configured to process information(e.g., data and control) from the as ultrasonic surgical instrument andcombination energy surgical instrument 7012 as described in FIGS.23A-23B, 24A-24B, 25-26, 27A-27C, 28A-28C, 29A-29C, 30A-30D, 31A-31D,32A-32E.

Additional details regarding the cloud analysis system can be found inU.S. Provisional Patent Application No. 62/659,900, titled METHOD OF HUBCOMMUNICATION, filed Apr. 19, 2018, which is hereby incorporated byreference herein in its entirety.

Situational Awareness

Although an “intelligent” device including control algorithms thatrespond to sensed data can be an improvement over a “dumb” device thatoperates without accounting for sensed data, some sensed data can beincomplete or inconclusive when considered in isolation, i.e., withoutthe context of the type of surgical procedure being performed or thetype of tissue that is being operated on. Without knowing the proceduralcontext (e.g., knowing the type of tissue being operated on or the typeof procedure being performed), the control algorithm may control themodular device incorrectly or suboptimally given the particularcontext-free sensed data. For example, the optimal manner for a controlalgorithm to control a surgical instrument in response to a particularsensed parameter can vary according to the particular tissue type beingoperated on. This is due to the fact that different tissue types havedifferent properties (e.g., resistance to tearing) and thus responddifferently to actions taken by surgical instruments. Therefore, it maybe desirable for a surgical instrument to take different actions evenwhen the same measurement for a particular parameter is sensed. As onespecific example, the optimal manner in which to control a surgicalstapling and cutting instrument in response to the instrument sensing anunexpectedly high force to close its end effector will vary dependingupon whether the tissue type is susceptible or resistant to tearing. Fortissues that are susceptible to tearing, such as lung tissue, theinstrument's control algorithm would optimally ramp down the motor inresponse to an unexpectedly high force to close to avoid tearing thetissue. For tissues that are resistant to tearing, such as stomachtissue, the instrument's control algorithm would optimally ramp up themotor in response to an unexpectedly high force to close to ensure thatthe end effector is clamped properly on the tissue. Without knowingwhether lung or stomach tissue has been clamped, the control algorithmmay make a suboptimal decision.

One solution utilizes a surgical hub including a system that isconfigured to derive information about the surgical procedure beingperformed based on data received from various data sources and thencontrol the paired modular devices accordingly. In other words, thesurgical hub is configured to infer information about the surgicalprocedure from received data and then control the modular devices pairedto the surgical hub based upon the inferred context of the surgicalprocedure. FIG. 14 illustrates a diagram of a situationally awaresurgical system 5100, in accordance with at least one aspect of thepresent disclosure. In some exemplifications, the data sources 5126include, for example, the modular devices 5102 (which can includesensors configured to detect parameters associated with the patientand/or the modular device itself), databases 5122 (e.g., an EMR databasecontaining patient records), and patient monitoring devices 5124 (e.g.,a blood pressure (BP) monitor and an electrocardiography (EKG) monitor).

A surgical hub 5104, which may be similar to the hub 106 in manyrespects, can be configured to derive the contextual informationpertaining to the surgical procedure from the data based upon, forexample, the particular combination(s) of received data or theparticular order in which the data is received from the data sources5126. The contextual information inferred from the received data caninclude, for example, the type of surgical procedure being performed,the particular step of the surgical procedure that the surgeon isperforming, the type of tissue being operated on, or the body cavitythat is the subject of the procedure. This ability by some aspects ofthe surgical hub 5104 to derive or infer information related to thesurgical procedure from received data can be referred to as “situationalawareness.” In one exemplification, the surgical hub 5104 canincorporate a situational awareness system, which is the hardware and/orprogramming associated with the surgical hub 5104 that derivescontextual information pertaining to the surgical procedure from thereceived data.

The situational awareness system of the surgical hub 5104 can beconfigured to derive the contextual information from the data receivedfrom the data sources 5126 in a variety of different ways. In oneexemplification, the situational awareness system includes a patternrecognition system, or machine learning system (e.g., an artificialneural network), that has been trained on training data to correlatevarious inputs (e.g., data from databases 5122, patient monitoringdevices 5124, and/or modular devices 5102) to corresponding contextualinformation regarding a surgical procedure. In other words, a machinelearning system can be trained to accurately derive contextualinformation regarding a surgical procedure from the provided inputs. Inanother exemplification, the situational awareness system can include alookup table storing pre-characterized contextual information regardinga surgical procedure in association with one or more inputs (or rangesof inputs) corresponding to the contextual information. In response to aquery with one or more inputs, the lookup table can return thecorresponding contextual information for the situational awarenesssystem for controlling the modular devices 5102. In one exemplification,the contextual information received by the situational awareness systemof the surgical hub 5104 is associated with a particular controladjustment or set of control adjustments for one or more modular devices5102. In another exemplification, the situational awareness systemincludes a further machine learning system, lookup table, or other suchsystem, which generates or retrieves one or more control adjustments forone or more modular devices 5102 when provided the contextualinformation as input.

A surgical hub 5104 incorporating a situational awareness systemprovides a number of benefits for the surgical system 5100. One benefitincludes improving the interpretation of sensed and collected data,which would in turn improve the processing accuracy and/or the usage ofthe data during the course of a surgical procedure. To return to aprevious example, a situationally aware surgical hub 5104 coulddetermine what type of tissue was being operated on; therefore, when anunexpectedly high force to close the surgical instrument's end effectoris detected, the situationally aware surgical hub 5104 could correctlyramp up or ramp down the motor of the surgical instrument for the typeof tissue.

As another example, the type of tissue being operated can affect theadjustments that are made to the compression rate and load thresholds ofa surgical stapling and cutting instrument for a particular tissue gapmeasurement. A situationally aware surgical hub 5104 could infer whethera surgical procedure being performed is a thoracic or an abdominalprocedure, allowing the surgical hub 5104 to determine whether thetissue clamped by an end effector of the surgical stapling and cuttinginstrument is lung (for a thoracic procedure) or stomach (for anabdominal procedure) tissue. The surgical hub 5104 could then adjust thecompression rate and load thresholds of the surgical stapling andcutting instrument appropriately for the type of tissue.

As yet another example, the type of body cavity being operated in duringan insufflation procedure can affect the function of a smoke evacuator.A situationally aware surgical hub 5104 could determine whether thesurgical site is under pressure (by determining that the surgicalprocedure is utilizing insufflation) and determine the procedure type.As a procedure type is generally performed in a specific body cavity,the surgical hub 5104 could then control the motor rate of the smokeevacuator appropriately for the body cavity being operated in. Thus, asituationally aware surgical hub 5104 could provide a consistent amountof smoke evacuation for both thoracic and abdominal procedures.

As yet another example, the type of procedure being performed can affectthe optimal energy level for an ultrasonic surgical instrument or radiofrequency (RF) electrosurgical instrument to operate at. Arthroscopicprocedures, for example, require higher energy levels because the endeffector of the ultrasonic surgical instrument or RF electrosurgicalinstrument is immersed in fluid. A situationally aware surgical hub 5104could determine whether the surgical procedure is an arthroscopicprocedure. The surgical hub 5104 could then adjust the RF power level orthe ultrasonic amplitude of the generator (i.e., “energy level”) tocompensate for the fluid filled environment. Relatedly, the type oftissue being operated on can affect the optimal energy level for anultrasonic surgical instrument or RF electrosurgical instrument tooperate at. A situationally aware surgical hub 5104 could determine whattype of surgical procedure is being performed and then customize theenergy level for the ultrasonic surgical instrument or RFelectrosurgical instrument, respectively, according to the expectedtissue profile for the surgical procedure. Furthermore, a situationallyaware surgical hub 5104 can be configured to adjust the energy level forthe ultrasonic surgical instrument or RF electrosurgical instrumentthroughout the course of a surgical procedure, rather than just on aprocedure-by-procedure basis. A situationally aware surgical hub 5104could determine what step of the surgical procedure is being performedor will subsequently be performed and then update the control algorithmsfor the generator and/or ultrasonic surgical instrument or RFelectrosurgical instrument to set the energy level at a valueappropriate for the expected tissue type according to the surgicalprocedure step.

As yet another example, data can be drawn from additional data sources5126 to improve the conclusions that the surgical hub 5104 draws fromone data source 5126. A situationally aware surgical hub 5104 couldaugment data that it receives from the modular devices 5102 withcontextual information that it has built up regarding the surgicalprocedure from other data sources 5126. For example, a situationallyaware surgical hub 5104 can be configured to determine whetherhemostasis has occurred (i.e., whether bleeding at a surgical site hasstopped) according to video or image data received from a medicalimaging device. However, in some cases the video or image data can beinconclusive. Therefore, in one exemplification, the surgical hub 5104can be further configured to compare a physiologic measurement (e.g.,blood pressure sensed by a BP monitor communicably connected to thesurgical hub 5104) with the visual or image data of hemostasis (e.g.,from a medical imaging device 124 (FIG. 2) communicably coupled to thesurgical hub 5104) to make a determination on the integrity of thestaple line or tissue weld. In other words, the situational awarenesssystem of the surgical hub 5104 can consider the physiologicalmeasurement data to provide additional context in analyzing thevisualization data. The additional context can be useful when thevisualization data may be inconclusive or incomplete on its own.

Another benefit includes proactively and automatically controlling thepaired modular devices 5102 according to the particular step of thesurgical procedure that is being performed to reduce the number of timesthat medical personnel are required to interact with or control thesurgical system 5100 during the course of a surgical procedure. Forexample, a situationally aware surgical hub 5104 could proactivelyactivate the generator to which an RF electrosurgical instrument isconnected if it determines that a subsequent step of the procedurerequires the use of the instrument. Proactively activating the energysource allows the instrument to be ready for use a soon as the precedingstep of the procedure is completed.

As another example, a situationally aware surgical hub 5104 coulddetermine whether the current or subsequent step of the surgicalprocedure requires a different view or degree of magnification on thedisplay according to the feature(s) at the surgical site that thesurgeon is expected to need to view. The surgical hub 5104 could thenproactively change the displayed view (supplied by, e.g., a medicalimaging device for the visualization system 108) accordingly so that thedisplay automatically adjusts throughout the surgical procedure.

As yet another example, a situationally aware surgical hub 5104 coulddetermine which step of the surgical procedure is being performed orwill subsequently be performed and whether particular data orcomparisons between data will be required for that step of the surgicalprocedure. The surgical hub 5104 can be configured to automatically callup data screens based upon the step of the surgical procedure beingperformed, without waiting for the surgeon to ask for the particularinformation.

Another benefit includes checking for errors during the setup of thesurgical procedure or during the course of the surgical procedure. Forexample, a situationally aware surgical hub 5104 could determine whetherthe operating theater is setup properly or optimally for the surgicalprocedure to be performed. The surgical hub 5104 can be configured todetermine the type of surgical procedure being performed, retrieve thecorresponding checklists, product location, or setup needs (e.g., from amemory), and then compare the current operating theater layout to thestandard layout for the type of surgical procedure that the surgical hub5104 determines is being performed. In one exemplification, the surgicalhub 5104 can be configured to compare the list of items for theprocedure scanned by a suitable scanner, for example, and/or a list ofdevices paired with the surgical hub 5104 to a recommended oranticipated manifest of items and/or devices for the given surgicalprocedure. If there are any discontinuities between the lists, thesurgical hub 5104 can be configured to provide an alert indicating thata particular modular device 5102, patient monitoring device 5124, and/orother surgical item is missing. In one exemplification, the surgical hub5104 can be configured to determine the relative distance or position ofthe modular devices 5102 and patient monitoring devices 5124 viaproximity sensors, for example. The surgical hub 5104 can compare therelative positions of the devices to a recommended or anticipated layoutfor the particular surgical procedure. If there are any discontinuitiesbetween the layouts, the surgical hub 5104 can be configured to providean alert indicating that the current layout for the surgical proceduredeviates from the recommended layout.

As another example, a situationally aware surgical hub 5104 coulddetermine whether the surgeon (or other medical personnel) was making anerror or otherwise deviating from the expected course of action duringthe course of a surgical procedure. For example, the surgical hub 5104can be configured to determine the type of surgical procedure beingperformed, retrieve the corresponding list of steps or order ofequipment usage (e.g., from a memory), and then compare the steps beingperformed or the equipment being used during the course of the surgicalprocedure to the expected steps or equipment for the type of surgicalprocedure that the surgical hub 5104 determined is being performed. Inone exemplification, the surgical hub 5104 can be configured to providean alert indicating that an unexpected action is being performed or anunexpected device is being utilized at the particular step in thesurgical procedure.

Overall, the situational awareness system for the surgical hub 5104improves surgical procedure outcomes by adjusting the surgicalinstruments (and other modular devices 5102) for the particular contextof each surgical procedure (such as adjusting to different tissue types)and validating actions during a surgical procedure. The situationalawareness system also improves surgeons' efficiency in performingsurgical procedures by automatically suggesting next steps, providingdata, and adjusting displays and other modular devices 5102 in thesurgical theater according to the specific context of the procedure.

Referring now to FIG. 15, a timeline 5200 depicting situationalawareness of a hub, such as the surgical hub 106 or 206 (FIGS. 1-11),for example, is depicted. The timeline 5200 is an illustrative surgicalprocedure and the contextual information that the surgical hub 106, 206can derive from the data received from the data sources at each step inthe surgical procedure. The timeline 5200 depicts the typical steps thatwould be taken by the nurses, surgeons, and other medical personnelduring the course of a lung segmentectomy procedure, beginning withsetting up the operating theater and ending with transferring thepatient to a post-operative recovery room.

The situationally aware surgical hub 106, 206 receives data from thedata sources throughout the course of the surgical procedure, includingdata generated each time medical personnel utilize a modular device thatis paired with the surgical hub 106, 206. The surgical hub 106, 206 canreceive this data from the paired modular devices and other data sourcesand continually derive inferences (i.e., contextual information) aboutthe ongoing procedure as new data is received, such as which step of theprocedure is being performed at any given time. The situationalawareness system of the surgical hub 106, 206 is able to, for example,record data pertaining to the procedure for generating reports, verifythe steps being taken by the medical personnel, provide data or prompts(e.g., via a display screen) that may be pertinent for the particularprocedural step, adjust modular devices based on the context (e.g.,activate monitors, adjust the field of view (FOV) of the medical imagingdevice, or change the energy level of an ultrasonic surgical instrumentor RF electrosurgical instrument), and take any other such actiondescribed above.

As the first step S202 in this illustrative procedure, the hospitalstaff members retrieve the patient's EMR from the hospital's EMRdatabase. Based on select patient data in the EMR, the surgical hub 106,206 determines that the procedure to be performed is a thoracicprocedure.

Second step S204, the staff members scan the incoming medical suppliesfor the procedure. The surgical hub 106, 206 cross-references thescanned supplies with a list of supplies that are utilized in varioustypes of procedures and confirms that the mix of supplies corresponds toa thoracic procedure. Further, the surgical hub 106, 206 is also able todetermine that the procedure is not a wedge procedure (because theincoming supplies either lack certain supplies that are necessary for athoracic wedge procedure or do not otherwise correspond to a thoracicwedge procedure).

Third step S206, the medical personnel scan the patient band via ascanner that is communicably connected to the surgical hub 106, 206. Thesurgical hub 106, 206 can then confirm the patient's identity based onthe scanned data.

Fourth step S208, the medical staff turns on the auxiliary equipment.The auxiliary equipment being utilized can vary according to the type ofsurgical procedure and the techniques to be used by the surgeon, but inthis illustrative case they include a smoke evacuator, insufflator, andmedical imaging device. When activated, the auxiliary equipment that aremodular devices can automatically pair with the surgical hub 106, 206that is located within a particular vicinity of the modular devices aspart of their initialization process. The surgical hub 106, 206 can thenderive contextual information about the surgical procedure by detectingthe types of modular devices that pair with it during this pre-operativeor initialization phase. In this particular example, the surgical hub106, 206 determines that the surgical procedure is a VATS procedurebased on this particular combination of paired modular devices. Based onthe combination of the data from the patient's EMR, the list of medicalsupplies to be used in the procedure, and the type of modular devicesthat connect to the hub, the surgical hub 106, 206 can generally inferthe specific procedure that the surgical team will be performing. Oncethe surgical hub 106, 206 knows what specific procedure is beingperformed, the surgical hub 106, 206 can then retrieve the steps of thatprocedure from a memory or from the cloud and then cross-reference thedata it subsequently receives from the connected data sources (e.g.,modular devices and patient monitoring devices) to infer what step ofthe surgical procedure the surgical team is performing.

Fifth step S210, the staff members attach the EKG electrodes and otherpatient monitoring devices to the patient. The EKG electrodes and otherpatient monitoring devices are able to pair with the surgical hub 106,206. As the surgical hub 106, 206 begins receiving data from the patientmonitoring devices, the surgical hub 106, 206 thus confirms that thepatient is in the operating theater.

Sixth step S212, the medical personnel induce anesthesia in the patient.The surgical hub 106, 206 can infer that the patient is under anesthesiabased on data from the modular devices and/or patient monitoringdevices, including EKG data, blood pressure data, ventilator data, orcombinations thereof, for example. Upon completion of the sixth stepS212, the pre-operative portion of the lung segmentectomy procedure iscompleted and the operative portion begins.

Seventh step S214, the patient's lung that is being operated on iscollapsed (while ventilation is switched to the contralateral lung). Thesurgical hub 106, 206 can infer from the ventilator data that thepatient's lung has been collapsed, for example. The surgical hub 106,206 can infer that the operative portion of the procedure has commencedas it can compare the detection of the patient's lung collapsing to theexpected steps of the procedure (which can be accessed or retrievedpreviously) and thereby determine that collapsing the lung is the firstoperative step in this particular procedure.

Eighth step S216, the medical imaging device (e.g., a scope) is insertedand video from the medical imaging device is initiated. The surgical hub106, 206 receives the medical imaging device data (i.e., video or imagedata) through its connection to the medical imaging device. Upon receiptof the medical imaging device data, the surgical hub 106, 206 candetermine that the laparoscopic portion of the surgical procedure hascommenced. Further, the surgical hub 106, 206 can determine that theparticular procedure being performed is a segmentectomy, as opposed to alobectomy (note that a wedge procedure has already been discounted bythe surgical hub 106, 206 based on data received at the second step S204of the procedure). The data from the medical imaging device 124 (FIG. 2)can be utilized to determine contextual information regarding the typeof procedure being performed in a number of different ways, including bydetermining the angle at which the medical imaging device is orientedwith respect to the visualization of the patient's anatomy, monitoringthe number or medical imaging devices being utilized (i.e., that areactivated and paired with the surgical hub 106, 206), and monitoring thetypes of visualization devices utilized. For example, one technique forperforming a VATS lobectomy places the camera in the lower anteriorcorner of the patient's chest cavity above the diaphragm, whereas onetechnique for performing a VATS segmentectomy places the camera in ananterior intercostal position relative to the segmental fissure. Usingpattern recognition or machine learning techniques, for example, thesituational awareness system can be trained to recognize the positioningof the medical imaging device according to the visualization of thepatient's anatomy. As another example, one technique for performing aVATS lobectomy utilizes a single medical imaging device, whereas anothertechnique for performing a VATS segmentectomy utilizes multiple cameras.As yet another example, one technique for performing a VATSsegmentectomy utilizes an infrared light source (which can becommunicably coupled to the surgical hub as part of the visualizationsystem) to visualize the segmental fissure, which is not utilized in aVATS lobectomy. By tracking any or all of this data from the medicalimaging device, the surgical hub 106, 206 can thereby determine thespecific type of surgical procedure being performed and/or the techniquebeing used for a particular type of surgical procedure.

Ninth step S218, the surgical team begins the dissection step of theprocedure. The surgical hub 106, 206 can infer that the surgeon is inthe process of dissecting to mobilize the patient's lung because itreceives data from the RF or ultrasonic generator indicating that anenergy instrument is being fired. The surgical hub 106, 206 cancross-reference the received data with the retrieved steps of thesurgical procedure to determine that an energy instrument being fired atthis point in the process (i.e., after the completion of the previouslydiscussed steps of the procedure) corresponds to the dissection step. Incertain instances, the energy instrument can be an energy tool mountedto a robotic arm of a robotic surgical system.

Tenth step S220, the surgical team proceeds to the ligation step of theprocedure. The surgical hub 106, 206 can infer that the surgeon isligating arteries and veins because it receives data from the surgicalstapling and cutting instrument indicating that the instrument is beingfired. Similarly to the prior step, the surgical hub 106, 206 can derivethis inference by cross-referencing the receipt of data from thesurgical stapling and cutting instrument with the retrieved steps in theprocess. In certain instances, the surgical instrument can be a surgicaltool mounted to a robotic arm of a robotic surgical system.

Eleventh step S222, the segmentectomy portion of the procedure isperformed. The surgical hub 106, 206 can infer that the surgeon istransecting the parenchyma based on data from the surgical stapling andcutting instrument, including data from its cartridge. The cartridgedata can correspond to the size or type of staple being fired by theinstrument, for example. As different types of staples are utilized fordifferent types of tissues, the cartridge data can thus indicate thetype of tissue being stapled and/or transected. In this case, the typeof staple being fired is utilized for parenchyma (or other similartissue types), which allows the surgical hub 106, 206 to infer that thesegmentectomy portion of the procedure is being performed.

Twelfth step S224, the node dissection step is then performed. Thesurgical hub 106, 206 can infer that the surgical team is dissecting thenode and performing a leak test based on data received from thegenerator indicating that an RF or ultrasonic instrument is being fired.For this particular procedure, an RF or ultrasonic instrument beingutilized after parenchyma was transected corresponds to the nodedissection step, which allows the surgical hub 106, 206 to make thisinference. It should be noted that surgeons regularly switch back andforth between surgical stapling/cutting instruments and surgical energy(i.e., RF or ultrasonic) instruments depending upon the particular stepin the procedure because different instruments are better adapted forparticular tasks. Therefore, the particular sequence in which thestapling/cutting instruments and surgical energy instruments are usedcan indicate what step of the procedure the surgeon is performing.Moreover, in certain instances, robotic tools can be utilized for one ormore steps in a surgical procedure and/or handheld surgical instrumentscan be utilized for one or more steps in the surgical procedure. Thesurgeon(s) can alternate between robotic tools and handheld surgicalinstruments and/or can use the devices concurrently, for example. Uponcompletion of the twelfth step S224, the incisions are closed up and thepost-operative portion of the procedure begins.

Thirteenth step S226, the patient's anesthesia is reversed. The surgicalhub 106, 206 can infer that the patient is emerging from the anesthesiabased on the ventilator data (i.e., the patient's breathing rate beginsincreasing), for example.

Lastly, the fourteenth step S228 is that the medical personnel removethe various patient monitoring devices from the patient. The surgicalhub 106, 206 can thus infer that the patient is being transferred to arecovery room when the hub loses EKG, BP, and other data from thepatient monitoring devices. As can be seen from the description of thisillustrative procedure, the surgical hub 106, 206 can determine or inferwhen each step of a given surgical procedure is taking place accordingto data received from the various data sources that are communicablycoupled to the surgical hub 106, 206.

Situational awareness is further described in U.S. Provisional PatentApplication Ser. No. 62/659,900, titled METHOD OF HUB COMMUNICATION,filed Apr. 19, 2018, which is herein incorporated by reference in itsentirety. In certain instances, operation of a robotic surgical system,including the various robotic surgical systems disclosed herein, forexample, can be controlled by the hub 106, 206 based on its situationalawareness and/or feedback from the components thereof and/or based oninformation from the cloud 104.

In one aspect, as described hereinbelow with reference to FIGS. 24-40,the modular device 5102 is implemented as ultrasonic surgicalinstruments and combination energy surgical instruments 7012 asdescribed in FIGS. 23A-23B, 24A-24B, 25-26, 27A-27C, 28A-28C, 29A-29C,30A-30D, 31A-31D, 32A-32E. Accordingly, the modular device 5102implemented as an ultrasonic surgical instrument and combination energysurgical instrument 7012 as described in FIGS. 23A-23B, 24A-24B,_25-26,27A-27C, 28A-28C, 29A-29C, 30A-30D, 31A-31D, 32A-32E is configured tooperate as a data source 5126 and to interact with the database 5122 andpatient monitoring devices 5124. The modular device 5102 implemented asa ultrasonic surgical instrument and combination energy surgicalinstrument 7012 as described in FIGS. 23A-23B, 24A-24B, 25-26, 27A-27C,28A-28C, 29A-29C, 30A-30D, 31A-31D, 32A-32E is further configured tointeract with the surgical hub 5104 to provide information (e.g., dataand control) to the surgical hub 5104 and receive information (e.g.,data and control) from the surgical hub 5104.

In one aspect, as described hereinbelow with reference to FIGS. 24-40,the modular device 5102 is implemented as ultrasonic surgicalinstruments and combination energy surgical instruments 7012 asdescribed in FIGS. 23A-23B, 24A-24B, 25-26, 27A-27C, 28A-28C, 29A-29C,30A-30D, 31A-31D, 32A-32E. Accordingly, the modular device 5102implemented as a ultrasonic surgical instrument and combination energysurgical instrument 7012 as described in FIGS. 23A-23B, 24A-24B, 25-26,27A-27C, 28A-28C, 29A-29C, 30A-30D, 31A-31D, 32A-32E is configured tooperate as a data source 5126 and to interact with the database 5122 andpatient monitoring devices 5124. The modular device 5102 implemented asa ultrasonic surgical instrument and combination energy surgicalinstrument 7012 as described in FIGS. 23A-23B, 24A-24B, 25-26, 27A-27C,28A-28C, 29A-29C, 30A-30D, 31A-31D, 32A-32E is further configured tointeract with the surgical hub 5104 to provide information (e.g., dataand control) to the surgical hub 5104 and receive information (e.g.,data and control) from the surgical hub 5104.

Generator Hardware

FIG. 16 is a schematic diagram of a robotic surgical instrument 700configured to operate a surgical tool described herein according to oneaspect of this disclosure. The robotic surgical instrument 700 may beprogrammed or configured to control distal/proximal translation of adisplacement member, distal/proximal displacement of a closure tube,shaft rotation, and articulation, either with single or multiplearticulation drive links. In one aspect, the surgical instrument 700 maybe programmed or configured to individually control a firing member, aclosure member, a shaft member, or one or more articulation members, orcombinations thereof. The surgical instrument 700 comprises a controlcircuit 710 configured to control motor-driven firing members, closuremembers, shaft members, or one or more articulation members, orcombinations thereof.

In one aspect, the robotic surgical instrument 700 comprises a controlcircuit 710 configured to control a clamp arm 716 and a closure member714 portion of an end effector 702, an ultrasonic blade 718 coupled toan ultrasonic transducer 719 excited by an ultrasonic generator 721, ashaft 740, and one or more articulation members 742 a, 742 b via aplurality of motors 704 a-704 e. A position sensor 734 may be configuredto provide position feedback of the closure member 714 to the controlcircuit 710. Other sensors 738 may be configured to provide feedback tothe control circuit 710. A timer/counter 731 provides timing andcounting information to the control circuit 710. An energy source 712may be provided to operate the motors 704 a-704 e, and a current sensor736 provides motor current feedback to the control circuit 710. Themotors 704 a-704 e can be operated individually by the control circuit710 in an open-loop or closed-loop feedback control.

In one aspect, the control circuit 710 may comprise one or moremicrocontrollers, microprocessors, or other suitable processors forexecuting instructions that cause the processor or processors to performone or more tasks. In one aspect, a timer/counter 731 provides an outputsignal, such as the elapsed time or a digital count, to the controlcircuit 710 to correlate the position of the closure member 714 asdetermined by the position sensor 734 with the output of thetimer/counter 731 such that the control circuit 710 can determine theposition of the closure member 714 at a specific time (t) relative to astarting position or the time (t) when the closure member 714 is at aspecific position relative to a starting position. The timer/counter 731may be configured to measure elapsed time, count external events, ortime external events.

In one aspect, the control circuit 710 may be programmed to controlfunctions of the end effector 702 based on one or more tissueconditions. The control circuit 710 may be programmed to sense tissueconditions, such as thickness, either directly or indirectly, asdescribed herein. The control circuit 710 may be programmed to select afiring control program or closure control program based on tissueconditions. A firing control program may describe the distal motion ofthe displacement member. Different firing control programs may beselected to better treat different tissue conditions. For example, whenthicker tissue is present, the control circuit 710 may be programmed totranslate the displacement member at a lower velocity and/or with lowerpower. When thinner tissue is present, the control circuit 710 may beprogrammed to translate the displacement member at a higher velocityand/or with higher power. A closure control program may control theclosure force applied to the tissue by the clamp arm 716. Other controlprograms control the rotation of the shaft 740 and the articulationmembers 742 a, 742 b.

In one aspect, the control circuit 710 may generate motor set pointsignals. The motor set point signals may be provided to various motorcontrollers 708 a-708 e. The motor controllers 708 a-708 e may compriseone or more circuits configured to provide motor drive signals to themotors 704 a-704 e to drive the motors 704 a-704 e as described herein.In some examples, the motors 704 a-704 e may be brushed DC electricmotors. For example, the velocity of the motors 704 a-704 e may beproportional to the respective motor drive signals. In some examples,the motors 704 a-704 e may be brushless DC electric motors, and therespective motor drive signals may comprise a PWM signal provided to oneor more stator windings of the motors 704 a-704 e. Also, in someexamples, the motor controllers 708 a-708 e may be omitted and thecontrol circuit 710 may generate the motor drive signals directly.

In one aspect, the control circuit 710 may initially operate each of themotors 704 a-704 e in an open-loop configuration for a first open-loopportion of a stroke of the displacement member. Based on the response ofthe robotic surgical instrument 700 during the open-loop portion of thestroke, the control circuit 710 may select a firing control program in aclosed-loop configuration. The response of the instrument may include atranslation distance of the displacement member during the open-loopportion, a time elapsed during the open-loop portion, the energyprovided to one of the motors 704 a-704 e during the open-loop portion,a sum of pulse widths of a motor drive signal, etc. After the open-loopportion, the control circuit 710 may implement the selected firingcontrol program for a second portion of the displacement member stroke.For example, during a closed-loop portion of the stroke, the controlcircuit 710 may modulate one of the motors 704 a-704 e based ontranslation data describing a position of the displacement member in aclosed-loop manner to translate the displacement member at a constantvelocity.

In one aspect, the motors 704 a-704 e may receive power from an energysource 712. The energy source 712 may be a DC power supply driven by amain alternating current power source, a battery, a super capacitor, orany other suitable energy source. The motors 704 a-704 e may bemechanically coupled to individual movable mechanical elements such asthe closure member 714, clamp arm 716, shaft 740, articulation 742 a,and articulation 742 b via respective transmissions 706 a-706 e. Thetransmissions 706 a-706 e may include one or more gears or other linkagecomponents to couple the motors 704 a-704 e to movable mechanicalelements. A position sensor 734 may sense a position of the closuremember 714. The position sensor 734 may be or include any type of sensorthat is capable of generating position data that indicate a position ofthe closure member 714. In some examples, the position sensor 734 mayinclude an encoder configured to provide a series of pulses to thecontrol circuit 710 as the closure member 714 translates distally andproximally. The control circuit 710 may track the pulses to determinethe position of the closure member 714. Other suitable position sensorsmay be used, including, for example, a proximity sensor. Other types ofposition sensors may provide other signals indicating motion of theclosure member 714. Also, in some examples, the position sensor 734 maybe omitted. Where any of the motors 704 a-704 e is a stepper motor, thecontrol circuit 710 may track the position of the closure member 714 byaggregating the number and direction of steps that the motor 704 hasbeen instructed to execute. The position sensor 734 may be located inthe end effector 702 or at any other portion of the instrument. Theoutputs of each of the motors 704 a-704 e include a torque sensor 744a-744 e to sense force and have an encoder to sense rotation of thedrive shaft.

In one aspect, the control circuit 710 is configured to drive a firingmember such as the closure member 714 portion of the end effector 702.The control circuit 710 provides a motor set point to a motor control708 a, which provides a drive signal to the motor 704 a. The outputshaft of the motor 704 a is coupled to a torque sensor 744 a. The torquesensor 744 a is coupled to a transmission 706 a which is coupled to theclosure member 714. The transmission 706 a comprises movable mechanicalelements such as rotating elements and a firing member to control themovement of the closure member 714 distally and proximally along alongitudinal axis of the end effector 702. In one aspect, the motor 704a may be coupled to the knife gear assembly, which includes a knife gearreduction set that includes a first knife drive gear and a second knifedrive gear. A torque sensor 744 a provides a firing force feedbacksignal to the control circuit 710. The firing force signal representsthe force required to fire or displace the closure member 714. Aposition sensor 734 may be configured to provide the position of theclosure member 714 along the firing stroke or the position of the firingmember as a feedback signal to the control circuit 710. The end effector702 may include additional sensors 738 configured to provide feedbacksignals to the control circuit 710. When ready to use, the controlcircuit 710 may provide a firing signal to the motor control 708 a. Inresponse to the firing signal, the motor 704 a may drive the firingmember distally along the longitudinal axis of the end effector 702 froma proximal stroke start position to a stroke end position distal to thestroke start position. As the closure member 714 translates distally,the clamp arm 716 closes towards the ultrasonic blade 718.

In one aspect, the control circuit 710 is configured to drive a closuremember such as the clamp arm 716 portion of the end effector 702. Thecontrol circuit 710 provides a motor set point to a motor control 708 b,which provides a drive signal to the motor 704 b. The output shaft ofthe motor 704 b is coupled to a torque sensor 744 b. The torque sensor744 b is coupled to a transmission 706 b which is coupled to the clamparm 716. The transmission 706 b comprises movable mechanical elementssuch as rotating elements and a closure member to control the movementof the clamp arm 716 from the open and closed positions. In one aspect,the motor 704 b is coupled to a closure gear assembly, which includes aclosure reduction gear set that is supported in meshing engagement withthe closure spur gear. The torque sensor 744 b provides a closure forcefeedback signal to the control circuit 710. The closure force feedbacksignal represents the closure force applied to the clamp arm 716. Theposition sensor 734 may be configured to provide the position of theclosure member as a feedback signal to the control circuit 710.Additional sensors 738 in the end effector 702 may provide the closureforce feedback signal to the control circuit 710. The pivotable clamparm 716 is positioned opposite the ultrasonic blade 718. When ready touse, the control circuit 710 may provide a closure signal to the motorcontrol 708 b. In response to the closure signal, the motor 704 badvances a closure member to grasp tissue between the clamp arm 716 andthe ultrasonic blade 718.

In one aspect, the control circuit 710 is configured to rotate a shaftmember such as the shaft 740 to rotate the end effector 702. The controlcircuit 710 provides a motor set point to a motor control 708 c, whichprovides a drive signal to the motor 704 c. The output shaft of themotor 704 c is coupled to a torque sensor 744 c. The torque sensor 744 cis coupled to a transmission 706 c which is coupled to the shaft 740.The transmission 706 c comprises movable mechanical elements such asrotating elements to control the rotation of the shaft 740 clockwise orcounterclockwise up to and over 360°. In one aspect, the motor 704 c iscoupled to the rotational transmission assembly, which includes a tubegear segment that is formed on (or attached to) the proximal end of theproximal closure tube for operable engagement by a rotational gearassembly that is operably supported on the tool mounting plate. Thetorque sensor 744 c provides a rotation force feedback signal to thecontrol circuit 710. The rotation force feedback signal represents therotation force applied to the shaft 740. The position sensor 734 may beconfigured to provide the position of the closure member as a feedbacksignal to the control circuit 710. Additional sensors 738 such as ashaft encoder may provide the rotational position of the shaft 740 tothe control circuit 710.

In one aspect, the control circuit 710 is configured to articulate theend effector 702. The control circuit 710 provides a motor set point toa motor control 708 d, which provides a drive signal to the motor 704 d.The output shaft of the motor 704 d is coupled to a torque sensor 744 d.The torque sensor 744 d is coupled to a transmission 706 d which iscoupled to an articulation member 742 a. The transmission 706 dcomprises movable mechanical elements such as articulation elements tocontrol the articulation of the end effector 702±65°. In one aspect, themotor 704 d is coupled to an articulation nut, which is rotatablyjournaled on the proximal end portion of the distal spine portion and isrotatably driven thereon by an articulation gear assembly. The torquesensor 744 d provides an articulation force feedback signal to thecontrol circuit 710. The articulation force feedback signal representsthe articulation force applied to the end effector 702. Sensors 738,such as an articulation encoder, may provide the articulation positionof the end effector 702 to the control circuit 710.

In another aspect, the articulation function of the robotic surgicalsystem 700 may comprise two articulation members, or links, 742 a, 742b. These articulation members 742 a, 742 b are driven by separate diskson the robot interface (the rack) which are driven by the two motors 708d, 708 e. When the separate firing motor 704 a is provided, each ofarticulation links 742 a, 742 b can be antagonistically driven withrespect to the other link in order to provide a resistive holding motionand a load to the head when it is not moving and to provide anarticulation motion as the head is articulated. The articulation members742 a, 742 b attach to the head at a fixed radius as the head isrotated. Accordingly, the mechanical advantage of the push-and-pull linkchanges as the head is rotated. This change in the mechanical advantagemay be more pronounced with other articulation link drive systems.

In one aspect, the one or more motors 704 a-704 e may comprise a brushedDC motor with a gearbox and mechanical links to a firing member, closuremember, or articulation member. Another example includes electric motors704 a-704 e that operate the movable mechanical elements such as thedisplacement member, articulation links, closure tube, and shaft. Anoutside influence is an unmeasured, unpredictable influence of thingslike tissue, surrounding bodies, and friction on the physical system.Such outside influence can be referred to as drag, which acts inopposition to one of electric motors 704 a-704 e. The outside influence,such as drag, may cause the operation of the physical system to deviatefrom a desired operation of the physical system.

In one aspect, the position sensor 734 may be implemented as an absolutepositioning system. In one aspect, the position sensor 734 may comprisea magnetic rotary absolute positioning system implemented as anAS5055EQFT single-chip magnetic rotary position sensor available fromAustria Microsystems, AG. The position sensor 734 may interface with thecontrol circuit 710 to provide an absolute positioning system. Theposition may include multiple Hall-effect elements located above amagnet and coupled to a CORDIC processor, also known as thedigit-by-digit method and Volder's algorithm, that is provided toimplement a simple and efficient algorithm to calculate hyperbolic andtrigonometric functions that require only addition, subtraction,bitshift, and table lookup operations.

In one aspect, the control circuit 710 may be in communication with oneor more sensors 738. The sensors 738 may be positioned on the endeffector 702 and adapted to operate with the robotic surgical instrument700 to measure the various derived parameters such as the gap distanceversus time, tissue compression versus time, and anvil strain versustime. The sensors 738 may comprise a magnetic sensor, a magnetic fieldsensor, a strain gauge, a load cell, a pressure sensor, a force sensor,a torque sensor, an inductive sensor such as an eddy current sensor, aresistive sensor, a capacitive sensor, an optical sensor, and/or anyother suitable sensor for measuring one or more parameters of the endeffector 702. The sensors 738 may include one or more sensors. Thesensors 738 may be located on the clamp arm 716 to determine tissuelocation using segmented electrodes. The torque sensors 744 a-744 e maybe configured to sense force such as firing force, closure force, and/orarticulation force, among others. Accordingly, the control circuit 710can sense (1) the closure load experienced by the distal closure tubeand its position, (2) the firing member at the rack and its position,(3) what portion of the ultrasonic blade 718 has tissue on it, and (4)the load and position on both articulation rods.

In one aspect, the one or more sensors 738 may comprise a strain gauge,such as a micro-strain gauge, configured to measure the magnitude of thestrain in the clamp arm 716 during a clamped condition. The strain gaugeprovides an electrical signal whose amplitude varies with the magnitudeof the strain. The sensors 738 may comprise a pressure sensor configuredto detect a pressure generated by the presence of compressed tissuebetween the clamp arm 716 and the ultrasonic blade 718. The sensors 738may be configured to detect impedance of a tissue section locatedbetween the clamp arm 716 and the ultrasonic blade 718 that isindicative of the thickness and/or fullness of tissue locatedtherebetween.

In one aspect, the sensors 738 may be implemented as one or more limitswitches, electromechanical devices, solid-state switches, Hall-effectdevices, magneto-resistive (MR) devices, giant magneto-resistive (GMR)devices, magnetometers, among others. In other implementations, thesensors 738 may be implemented as solid-state switches that operateunder the influence of light, such as optical sensors, IR sensors,ultraviolet sensors, among others. Still, the switches may besolid-state devices such as transistors (e.g., FET, junction FET,MOSFET, bipolar, and the like). In other implementations, the sensors738 may include electrical conductorless switches, ultrasonic switches,accelerometers, and inertial sensors, among others.

In one aspect, the sensors 738 may be configured to measure forcesexerted on the clamp arm 716 by the closure drive system. For example,one or more sensors 738 can be at an interaction point between theclosure tube and the clamp arm 716 to detect the closure forces appliedby the closure tube to the clamp arm 716. The forces exerted on theclamp arm 716 can be representative of the tissue compressionexperienced by the tissue section captured between the clamp arm 716 andthe ultrasonic blade 718. The one or more sensors 738 can be positionedat various interaction points along the closure drive system to detectthe closure forces applied to the clamp arm 716 by the closure drivesystem. The one or more sensors 738 may be sampled in real time during aclamping operation by the processor of the control circuit 710. Thecontrol circuit 710 receives real-time sample measurements to provideand analyze time-based information and assess, in real time, closureforces applied to the clamp arm 716.

In one aspect, a current sensor 736 can be employed to measure thecurrent drawn by each of the motors 704 a-704 e. The force required toadvance any of the movable mechanical elements such as the closuremember 714 corresponds to the current drawn by one of the motors 704a-704 e. The force is converted to a digital signal and provided to thecontrol circuit 710. The control circuit 710 can be configured tosimulate the response of the actual system of the instrument in thesoftware of the controller. A displacement member can be actuated tomove the closure member 714 in the end effector 702 at or near a targetvelocity. The robotic surgical instrument 700 can include a feedbackcontroller, which can be one of any feedback controllers, including, butnot limited to a PID, a state feedback, a linear-quadratic (LQR), and/oran adaptive controller, for example. The robotic surgical instrument 700can include a power source to convert the signal from the feedbackcontroller into a physical input such as case voltage, PWM voltage,frequency modulated voltage, current, torque, and/or force, for example.Additional details are disclosed in U.S. patent application Ser. No.15/636,829, titled CLOSED LOOP VELOCITY CONTROL TECHNIQUES FOR ROBOTICSURGICAL INSTRUMENT, filed Jun. 29, 2017, which is herein incorporatedby reference in its entirety.

FIG. 17 illustrates a schematic diagram of a surgical instrument 750configured to control the distal translation of a displacement memberaccording to one aspect of this disclosure. In one aspect, the surgicalinstrument 750 is programmed to control the distal translation of adisplacement member such as the closure member 764. The surgicalinstrument 750 comprises an end effector 752 that may comprise a clamparm 766, a closure member 764, and an ultrasonic blade 768 coupled to anultrasonic transducer 769 driven by an ultrasonic generator 771.

The position, movement, displacement, and/or translation of a lineardisplacement member, such as the closure member 764, can be measured byan absolute positioning system, sensor arrangement, and position sensor784. Because the closure member 764 is coupled to a longitudinallymovable drive member, the position of the closure member 764 can bedetermined by measuring the position of the longitudinally movable drivemember employing the position sensor 784. Accordingly, in the followingdescription, the position, displacement, and/or translation of theclosure member 764 can be achieved by the position sensor 784 asdescribed herein. A control circuit 760 may be programmed to control thetranslation of the displacement member, such as the closure member 764.The control circuit 760, in some examples, may comprise one or moremicrocontrollers, microprocessors, or other suitable processors forexecuting instructions that cause the processor or processors to controlthe displacement member, e.g., the closure member 764, in the mannerdescribed. In one aspect, a timer/counter 781 provides an output signal,such as the elapsed time or a digital count, to the control circuit 760to correlate the position of the closure member 764 as determined by theposition sensor 784 with the output of the timer/counter 781 such thatthe control circuit 760 can determine the position of the closure member764 at a specific time (t) relative to a starting position. Thetimer/counter 781 may be configured to measure elapsed time, countexternal events, or time external events.

The control circuit 760 may generate a motor set point signal 772. Themotor set point signal 772 may be provided to a motor controller 758.The motor controller 758 may comprise one or more circuits configured toprovide a motor drive signal 774 to the motor 754 to drive the motor 754as described herein. In some examples, the motor 754 may be a brushed DCelectric motor. For example, the velocity of the motor 754 may beproportional to the motor drive signal 774. In some examples, the motor754 may be a brushless DC electric motor and the motor drive signal 774may comprise a PWM signal provided to one or more stator windings of themotor 754. Also, in some examples, the motor controller 758 may beomitted, and the control circuit 760 may generate the motor drive signal774 directly.

The motor 754 may receive power from an energy source 762. The energysource 762 may be or include a battery, a super capacitor, or any othersuitable energy source. The motor 754 may be mechanically coupled to theclosure member 764 via a transmission 756. The transmission 756 mayinclude one or more gears or other linkage components to couple themotor 754 to the closure member 764. A position sensor 784 may sense aposition of the closure member 764. The position sensor 784 may be orinclude any type of sensor that is capable of generating position datathat indicate a position of the closure member 764. In some examples,the position sensor 784 may include an encoder configured to provide aseries of pulses to the control circuit 760 as the closure member 764translates distally and proximally. The control circuit 760 may trackthe pulses to determine the position of the closure member 764. Othersuitable position sensors may be used, including, for example, aproximity sensor. Other types of position sensors may provide othersignals indicating motion of the closure member 764. Also, in someexamples, the position sensor 784 may be omitted. Where the motor 754 isa stepper motor, the control circuit 760 may track the position of theclosure member 764 by aggregating the number and direction of steps thatthe motor 754 has been instructed to execute. The position sensor 784may be located in the end effector 752 or at any other portion of theinstrument.

The control circuit 760 may be in communication with one or more sensors788. The sensors 788 may be positioned on the end effector 752 andadapted to operate with the surgical instrument 750 to measure thevarious derived parameters such as gap distance versus time, tissuecompression versus time, and anvil strain versus time. The sensors 788may comprise a magnetic sensor, a magnetic field sensor, a strain gauge,a pressure sensor, a force sensor, an inductive sensor such as an eddycurrent sensor, a resistive sensor, a capacitive sensor, an opticalsensor, and/or any other suitable sensor for measuring one or moreparameters of the end effector 752. The sensors 788 may include one ormore sensors.

The one or more sensors 788 may comprise a strain gauge, such as amicro-strain gauge, configured to measure the magnitude of the strain inthe clamp arm 766 during a clamped condition. The strain gauge providesan electrical signal whose amplitude varies with the magnitude of thestrain. The sensors 788 may comprise a pressure sensor configured todetect a pressure generated by the presence of compressed tissue betweenthe clamp arm 766 and the ultrasonic blade 768. The sensors 788 may beconfigured to detect impedance of a tissue section located between theclamp arm 766 and the ultrasonic blade 768 that is indicative of thethickness and/or fullness of tissue located therebetween.

The sensors 788 may be is configured to measure forces exerted on theclamp arm 766 by a closure drive system. For example, one or moresensors 788 can be at an interaction point between a closure tube andthe clamp arm 766 to detect the closure forces applied by a closure tubeto the clamp arm 766. The forces exerted on the clamp arm 766 can berepresentative of the tissue compression experienced by the tissuesection captured between the clamp arm 766 and the ultrasonic blade 768.The one or more sensors 788 can be positioned at various interactionpoints along the closure drive system to detect the closure forcesapplied to the clamp arm 766 by the closure drive system. The one ormore sensors 788 may be sampled in real time during a clamping operationby a processor of the control circuit 760. The control circuit 760receives real-time sample measurements to provide and analyze time-basedinformation and assess, in real time, closure forces applied to theclamp arm 766.

A current sensor 786 can be employed to measure the current drawn by themotor 754. The force required to advance the closure member 764corresponds to the current drawn by the motor 754. The force isconverted to a digital signal and provided to the control circuit 760.

The control circuit 760 can be configured to simulate the response ofthe actual system of the instrument in the software of the controller. Adisplacement member can be actuated to move a closure member 764 in theend effector 752 at or near a target velocity. The surgical instrument750 can include a feedback controller, which can be one of any feedbackcontrollers, including, but not limited to a PID, a state feedback, LQR,and/or an adaptive controller, for example. The surgical instrument 750can include a power source to convert the signal from the feedbackcontroller into a physical input such as case voltage, PWM voltage,frequency modulated voltage, current, torque, and/or force, for example.

The actual drive system of the surgical instrument 750 is configured todrive the displacement member, cutting member, or closure member 764, bya brushed DC motor with gearbox and mechanical links to an articulationand/or knife system. Another example is the electric motor 754 thatoperates the displacement member and the articulation driver, forexample, of an interchangeable shaft assembly. An outside influence isan unmeasured, unpredictable influence of things like tissue,surrounding bodies and friction on the physical system. Such outsideinfluence can be referred to as drag which acts in opposition to theelectric motor 754. The outside influence, such as drag, may cause theoperation of the physical system to deviate from a desired operation ofthe physical system.

Various example aspects are directed to a surgical instrument 750comprising an end effector 752 with motor-driven surgical sealing andcutting implements. For example, a motor 754 may drive a displacementmember distally and proximally along a longitudinal axis of the endeffector 752. The end effector 752 may comprise a pivotable clamp arm766 and, when configured for use, an ultrasonic blade 768 positionedopposite the clamp arm 766. A clinician may grasp tissue between theclamp arm 766 and the ultrasonic blade 768, as described herein. Whenready to use the instrument 750, the clinician may provide a firingsignal, for example by depressing a trigger of the instrument 750. Inresponse to the firing signal, the motor 754 may drive the displacementmember distally along the longitudinal axis of the end effector 752 froma proximal stroke begin position to a stroke end position distal of thestroke begin position. As the displacement member translates distally,the closure member 764 with a cutting element positioned at a distalend, may cut the tissue between the ultrasonic blade 768 and the clamparm 766.

In various examples, the surgical instrument 750 may comprise a controlcircuit 760 programmed to control the distal translation of thedisplacement member, such as the closure member 764, for example, basedon one or more tissue conditions. The control circuit 760 may beprogrammed to sense tissue conditions, such as thickness, eitherdirectly or indirectly, as described herein. The control circuit 760 maybe programmed to select a control program based on tissue conditions. Acontrol program may describe the distal motion of the displacementmember. Different control programs may be selected to better treatdifferent tissue conditions. For example, when thicker tissue ispresent, the control circuit 760 may be programmed to translate thedisplacement member at a lower velocity and/or with lower power. Whenthinner tissue is present, the control circuit 760 may be programmed totranslate the displacement member at a higher velocity and/or withhigher power.

In some examples, the control circuit 760 may initially operate themotor 754 in an open loop configuration for a first open loop portion ofa stroke of the displacement member. Based on a response of theinstrument 750 during the open loop portion of the stroke, the controlcircuit 760 may select a firing control program. The response of theinstrument may include, a translation distance of the displacementmember during the open loop portion, a time elapsed during the open loopportion, energy provided to the motor 754 during the open loop portion,a sum of pulse widths of a motor drive signal, etc. After the open loopportion, the control circuit 760 may implement the selected firingcontrol program for a second portion of the displacement member stroke.For example, during the closed loop portion of the stroke, the controlcircuit 760 may modulate the motor 754 based on translation datadescribing a position of the displacement member in a closed loop mannerto translate the displacement member at a constant velocity. Additionaldetails are disclosed in U.S. patent application Ser. No. 15/720,852,titled SYSTEM AND METHODS FOR CONTROLLING A DISPLAY OF A SURGICALINSTRUMENT, filed Sep. 29, 2017, which is herein incorporated byreference in its entirety.

FIG. 18 illustrates a schematic diagram of a surgical instrument 750configured to control the distal translation of a displacement memberaccording to one aspect of this disclosure. In one aspect, the surgicalinstrument 750 is programmed to control the distal translation of adisplacement member such as the closure member 764. The surgicalinstrument 750 comprises an end effector 752 that may comprise a clamparm 766, a closure member 764, and an ultrasonic blade 768 coupled to anultrasonic transducer 769 driven by an ultrasonic generator 771.

The position, movement, displacement, and/or translation of a lineardisplacement member, such as the closure member 764, can be measured byan absolute positioning system, sensor arrangement, and position sensor784. Because the closure member 764 is coupled to a longitudinallymovable drive member, the position of the closure member 764 can bedetermined by measuring the position of the longitudinally movable drivemember employing the position sensor 784. Accordingly, in the followingdescription, the position, displacement, and/or translation of theclosure member 764 can be achieved by the position sensor 784 asdescribed herein. A control circuit 760 may be programmed to control thetranslation of the displacement member, such as the closure member 764.The control circuit 760, in some examples, may comprise one or moremicrocontrollers, microprocessors, or other suitable processors forexecuting instructions that cause the processor or processors to controlthe displacement member, e.g., the closure member 764, in the mannerdescribed. In one aspect, a timer/counter 781 provides an output signal,such as the elapsed time or a digital count, to the control circuit 760to correlate the position of the closure member 764 as determined by theposition sensor 784 with the output of the timer/counter 781 such thatthe control circuit 760 can determine the position of the closure member764 at a specific time (t) relative to a starting position. Thetimer/counter 781 may be configured to measure elapsed time, countexternal events, or time external events.

The control circuit 760 may generate a motor set point signal 772. Themotor set point signal 772 may be provided to a motor controller 758.The motor controller 758 may comprise one or more circuits configured toprovide a motor drive signal 774 to the motor 754 to drive the motor 754as described herein. In some examples, the motor 754 may be a brushed DCelectric motor. For example, the velocity of the motor 754 may beproportional to the motor drive signal 774. In some examples, the motor754 may be a brushless DC electric motor and the motor drive signal 774may comprise a PWM signal provided to one or more stator windings of themotor 754. Also, in some examples, the motor controller 758 may beomitted, and the control circuit 760 may generate the motor drive signal774 directly.

The motor 754 may receive power from an energy source 762. The energysource 762 may be or include a battery, a super capacitor, or any othersuitable energy source. The motor 754 may be mechanically coupled to theclosure member 764 via a transmission 756. The transmission 756 mayinclude one or more gears or other linkage components to couple themotor 754 to the closure member 764. A position sensor 784 may sense aposition of the closure member 764. The position sensor 784 may be orinclude any type of sensor that is capable of generating position datathat indicate a position of the closure member 764. In some examples,the position sensor 784 may include an encoder configured to provide aseries of pulses to the control circuit 760 as the closure member 764translates distally and proximally. The control circuit 760 may trackthe pulses to determine the position of the closure member 764. Othersuitable position sensors may be used, including, for example, aproximity sensor. Other types of position sensors may provide othersignals indicating motion of the closure member 764. Also, in someexamples, the position sensor 784 may be omitted. Where the motor 754 isa stepper motor, the control circuit 760 may track the position of theclosure member 764 by aggregating the number and direction of steps thatthe motor 754 has been instructed to execute. The position sensor 784may be located in the end effector 752 or at any other portion of theinstrument.

The control circuit 760 may be in communication with one or more sensors788. The sensors 788 may be positioned on the end effector 752 andadapted to operate with the surgical instrument 750 to measure thevarious derived parameters such as gap distance versus time, tissuecompression versus time, and anvil strain versus time. The sensors 788may comprise a magnetic sensor, a magnetic field sensor, a strain gauge,a pressure sensor, a force sensor, an inductive sensor such as an eddycurrent sensor, a resistive sensor, a capacitive sensor, an opticalsensor, and/or any other suitable sensor for measuring one or moreparameters of the end effector 752. The sensors 788 may include one ormore sensors.

The one or more sensors 788 may comprise a strain gauge, such as amicro-strain gauge, configured to measure the magnitude of the strain inthe clamp arm 766 during a clamped condition. The strain gauge providesan electrical signal whose amplitude varies with the magnitude of thestrain. The sensors 788 may comprise a pressure sensor configured todetect a pressure generated by the presence of compressed tissue betweenthe clamp arm 766 and the ultrasonic blade 768. The sensors 788 may beconfigured to detect impedance of a tissue section located between theclamp arm 766 and the ultrasonic blade 768 that is indicative of thethickness and/or fullness of tissue located therebetween.

The sensors 788 may be is configured to measure forces exerted on theclamp arm 766 by a closure drive system. For example, one or moresensors 788 can be at an interaction point between a closure tube andthe clamp arm 766 to detect the closure forces applied by a closure tubeto the clamp arm 766. The forces exerted on the clamp arm 766 can berepresentative of the tissue compression experienced by the tissuesection captured between the clamp arm 766 and the ultrasonic blade 768.The one or more sensors 788 can be positioned at various interactionpoints along the closure drive system to detect the closure forcesapplied to the clamp arm 766 by the closure drive system. The one ormore sensors 788 may be sampled in real time during a clamping operationby a processor of the control circuit 760. The control circuit 760receives real-time sample measurements to provide and analyze time-basedinformation and assess, in real time, closure forces applied to theclamp arm 766.

A current sensor 786 can be employed to measure the current drawn by themotor 754. The force required to advance the closure member 764corresponds to the current drawn by the motor 754. The force isconverted to a digital signal and provided to the control circuit 760.

The control circuit 760 can be configured to simulate the response ofthe actual system of the instrument in the software of the controller. Adisplacement member can be actuated to move a closure member 764 in theend effector 752 at or near a target velocity. The surgical instrument750 can include a feedback controller, which can be one of any feedbackcontrollers, including, but not limited to a PID, a state feedback, LQR,and/or an adaptive controller, for example. The surgical instrument 750can include a power source to convert the signal from the feedbackcontroller into a physical input such as case voltage, PWM voltage,frequency modulated voltage, current, torque, and/or force, for example.

The actual drive system of the surgical instrument 750 is configured todrive the displacement member, cutting member, or closure member 764, bya brushed DC motor with gearbox and mechanical links to an articulationand/or knife system. Another example is the electric motor 754 thatoperates the displacement member and the articulation driver, forexample, of an interchangeable shaft assembly. An outside influence isan unmeasured, unpredictable influence of things like tissue,surrounding bodies and friction on the physical system. Such outsideinfluence can be referred to as drag which acts in opposition to theelectric motor 754. The outside influence, such as drag, may cause theoperation of the physical system to deviate from a desired operation ofthe physical system.

Various example aspects are directed to a surgical instrument 750comprising an end effector 752 with motor-driven surgical sealing andcutting implements. For example, a motor 754 may drive a displacementmember distally and proximally along a longitudinal axis of the endeffector 752. The end effector 752 may comprise a pivotable clamp arm766 and, when configured for use, an ultrasonic blade 768 positionedopposite the clamp arm 766. A clinician may grasp tissue between theclamp arm 766 and the ultrasonic blade 768, as described herein. Whenready to use the instrument 750, the clinician may provide a firingsignal, for example by depressing a trigger of the instrument 750. Inresponse to the firing signal, the motor 754 may drive the displacementmember distally along the longitudinal axis of the end effector 752 froma proximal stroke begin position to a stroke end position distal of thestroke begin position. As the displacement member translates distally,the closure member 764 with a cutting element positioned at a distalend, may cut the tissue between the ultrasonic blade 768 and the clamparm 766.

In various examples, the surgical instrument 750 may comprise a controlcircuit 760 programmed to control the distal translation of thedisplacement member, such as the closure member 764, for example, basedon one or more tissue conditions. The control circuit 760 may beprogrammed to sense tissue conditions, such as thickness, eitherdirectly or indirectly, as described herein. The control circuit 760 maybe programmed to select a control program based on tissue conditions. Acontrol program may describe the distal motion of the displacementmember. Different control programs may be selected to better treatdifferent tissue conditions. For example, when thicker tissue ispresent, the control circuit 760 may be programmed to translate thedisplacement member at a lower velocity and/or with lower power. Whenthinner tissue is present, the control circuit 760 may be programmed totranslate the displacement member at a higher velocity and/or withhigher power.

In some examples, the control circuit 760 may initially operate themotor 754 in an open loop configuration for a first open loop portion ofa stroke of the displacement member. Based on a response of theinstrument 750 during the open loop portion of the stroke, the controlcircuit 760 may select a firing control program. The response of theinstrument may include, a translation distance of the displacementmember during the open loop portion, a time elapsed during the open loopportion, energy provided to the motor 754 during the open loop portion,a sum of pulse widths of a motor drive signal, etc. After the open loopportion, the control circuit 760 may implement the selected firingcontrol program for a second portion of the displacement member stroke.For example, during the closed loop portion of the stroke, the controlcircuit 760 may modulate the motor 754 based on translation datadescribing a position of the displacement member in a closed loop mannerto translate the displacement member at a constant velocity. Additionaldetails are disclosed in U.S. patent application Ser. No. 15/720,852,titled SYSTEM AND METHODS FOR CONTROLLING A DISPLAY OF A SURGICALINSTRUMENT, filed Sep. 29, 2017, which is herein incorporated byreference in its entirety.

FIG. 18 is a schematic diagram of a surgical instrument 790 configuredto control various functions according to one aspect of this disclosure.In one aspect, the surgical instrument 790 is programmed to controldistal translation of a displacement member such as the closure member764. The surgical instrument 790 comprises an end effector 792 that maycomprise a clamp arm 766, a closure member 764, and an ultrasonic blade768 which may be interchanged with or work in conjunction with one ormore RF electrodes 796 (shown in dashed line). The ultrasonic blade 768is coupled to an ultrasonic transducer 769 driven by an ultrasonicgenerator 771.

In one aspect, sensors 788 may be implemented as a limit switch,electromechanical device, solid-state switches, Hall-effect devices, MRdevices, GMR devices, magnetometers, among others. In otherimplementations, the sensors 638 may be solid-state switches thatoperate under the influence of light, such as optical sensors, IRsensors, ultraviolet sensors, among others. Still, the switches may besolid-state devices such as transistors (e.g., FET, junction FET,MOSFET, bipolar, and the like). In other implementations, the sensors788 may include electrical conductorless switches, ultrasonic switches,accelerometers, and inertial sensors, among others.

In one aspect, the position sensor 784 may be implemented as an absolutepositioning system comprising a magnetic rotary absolute positioningsystem implemented as an AS5055EQFT single-chip magnetic rotary positionsensor available from Austria Microsystems, AG. The position sensor 784may interface with the control circuit 760 to provide an absolutepositioning system. The position may include multiple Hall-effectelements located above a magnet and coupled to a CORDIC processor, alsoknown as the digit-by-digit method and Volder's algorithm, that isprovided to implement a simple and efficient algorithm to calculatehyperbolic and trigonometric functions that require only addition,subtraction, bitshift, and table lookup operations.

In some examples, the position sensor 784 may be omitted. Where themotor 754 is a stepper motor, the control circuit 760 may track theposition of the closure member 764 by aggregating the number anddirection of steps that the motor has been instructed to execute. Theposition sensor 784 may be located in the end effector 792 or at anyother portion of the instrument.

The control circuit 760 may be in communication with one or more sensors788. The sensors 788 may be positioned on the end effector 792 andadapted to operate with the surgical instrument 790 to measure thevarious derived parameters such as gap distance versus time, tissuecompression versus time, and anvil strain versus time. The sensors 788may comprise a magnetic sensor, a magnetic field sensor, a strain gauge,a pressure sensor, a force sensor, an inductive sensor such as an eddycurrent sensor, a resistive sensor, a capacitive sensor, an opticalsensor, and/or any other suitable sensor for measuring one or moreparameters of the end effector 792. The sensors 788 may include one ormore sensors.

An RF energy source 794 is coupled to the end effector 792 and isapplied to the RF electrode 796 when the RF electrode 796 is provided inthe end effector 792 in place of the ultrasonic blade 768 or to work inconjunction with the ultrasonic blade 768. For example, the ultrasonicblade is made of electrically conductive metal and may be employed asthe return path for electrosurgical RF current. The control circuit 760controls the delivery of the RF energy to the RF electrode 796.

Additional details are disclosed in U.S. patent application Ser. No.15/636,096, titled SURGICAL SYSTEM COUPLABLE WITH STAPLE CARTRIDGE ANDRADIO FREQUENCY CARTRIDGE, AND METHOD OF USING SAME, filed Jun. 28,2017, which is herein incorporated by reference in its entirety.

FIG. 19 illustrates an example of a generator 900, which is one form ofa generator configured to couple to an ultrasonic instrument and furtherconfigured to execute adaptive ultrasonic blade control algorithms in asurgical data network comprising a modular communication hub. Thegenerator 900 is configured to deliver multiple energy modalities to asurgical instrument. The generator 900 provides RF and ultrasonicsignals for delivering energy to a surgical instrument eitherindependently or simultaneously. The RF and ultrasonic signals may beprovided alone or in combination and may be provided simultaneously. Asnoted above, at least one generator output can deliver multiple energymodalities (e.g., ultrasonic, bipolar or monopolar RF, irreversibleand/or reversible electroporation, and/or microwave energy, amongothers) through a single port, and these signals can be deliveredseparately or simultaneously to the end effector to treat tissue. Thegenerator 900 comprises a processor 902 coupled to a waveform generator904. The processor 902 and waveform generator 904 are configured togenerate a variety of signal waveforms based on information stored in amemory coupled to the processor 902, not shown for clarity ofdisclosure. The digital information associated with a waveform isprovided to the waveform generator 904 which includes one or more DACcircuits to convert the digital input into an analog output. The analogoutput is fed to an amplifier 1106 for signal conditioning andamplification. The conditioned and amplified output of the amplifier 906is coupled to a power transformer 908. The signals are coupled acrossthe power transformer 908 to the secondary side, which is in the patientisolation side. A first signal of a first energy modality is provided tothe surgical instrument between the terminals labeled ENERGY₁ andRETURN. A second signal of a second energy modality is coupled across acapacitor 910 and is provided to the surgical instrument between theterminals labeled ENERGY₂ and RETURN. It will be appreciated that morethan two energy modalities may be output and thus the subscript “n” maybe used to designate that up to n ENERGY_(n) terminals may be provided,where n is a positive integer greater than 1. It also will beappreciated that up to “n” return paths RETURN_(n) may be providedwithout departing from the scope of the present disclosure.

A first voltage sensing circuit 912 is coupled across the terminalslabeled ENERGY₁ and the RETURN path to measure the output voltagetherebetween. A second voltage sensing circuit 924 is coupled across theterminals labeled ENERGY₂ and the RETURN path to measure the outputvoltage therebetween. A current sensing circuit 914 is disposed inseries with the RETURN leg of the secondary side of the powertransformer 908 as shown to measure the output current for either energymodality. If different return paths are provided for each energymodality, then a separate current sensing circuit should be provided ineach return leg. The outputs of the first and second voltage sensingcircuits 912, 924 are provided to respective isolation transformers 916,922 and the output of the current sensing circuit 914 is provided toanother isolation transformer 918. The outputs of the isolationtransformers 916, 928, 922 in the on the primary side of the powertransformer 908 (non-patient isolated side) are provided to a one ormore ADC circuit 926. The digitized output of the ADC circuit 926 isprovided to the processor 902 for further processing and computation.The output voltages and output current feedback information can beemployed to adjust the output voltage and current provided to thesurgical instrument and to compute output impedance, among otherparameters. Input/output communications between the processor 902 andpatient isolated circuits is provided through an interface circuit 920.Sensors also may be in electrical communication with the processor 902by way of the interface circuit 920.

In one aspect, the impedance may be determined by the processor 902 bydividing the output of either the first voltage sensing circuit 912coupled across the terminals labeled ENERGY₁/RETURN or the secondvoltage sensing circuit 924 coupled across the terminals labeledENERGY₂/RETURN by the output of the current sensing circuit 914 disposedin series with the RETURN leg of the secondary side of the powertransformer 908. The outputs of the first and second voltage sensingcircuits 912, 924 are provided to separate isolations transformers 916,922 and the output of the current sensing circuit 914 is provided toanother isolation transformer 916. The digitized voltage and currentsensing measurements from the ADC circuit 926 are provided the processor902 for computing impedance. As an example, the first energy modalityENERGY₁ may be ultrasonic energy and the second energy modality ENERGY₂may be RF energy. Nevertheless, in addition to ultrasonic and bipolar ormonopolar RF energy modalities, other energy modalities includeirreversible and/or reversible electroporation and/or microwave energy,among others. Also, although the example illustrated in FIG. 19 shows asingle return path RETURN may be provided for two or more energymodalities, in other aspects, multiple return paths RETURN_(n) may beprovided for each energy modality ENERGY_(n). Thus, as described herein,the ultrasonic transducer impedance may be measured by dividing theoutput of the first voltage sensing circuit 912 by the current sensingcircuit 914 and the tissue impedance may be measured by dividing theoutput of the second voltage sensing circuit 924 by the current sensingcircuit 914.

As shown in FIG. 19, the generator 900 comprising at least one outputport can include a power transformer 908 with a single output and withmultiple taps to provide power in the form of one or more energymodalities, such as ultrasonic, bipolar or monopolar RF, irreversibleand/or reversible electroporation, and/or microwave energy, amongothers, for example, to the end effector depending on the type oftreatment of tissue being performed. For example, the generator 900 candeliver energy with higher voltage and lower current to drive anultrasonic transducer, with lower voltage and higher current to drive RFelectrodes for sealing tissue, or with a coagulation waveform for spotcoagulation using either monopolar or bipolar RF electrosurgicalelectrodes. The output waveform from the generator 900 can be steered,switched, or filtered to provide the frequency to the end effector ofthe surgical instrument. The connection of an ultrasonic transducer tothe generator 900 output would be preferably located between the outputlabeled ENERGY₁ and RETURN as shown in FIG. 18. In one example, aconnection of RF bipolar electrodes to the generator 900 output would bepreferably located between the output labeled ENERGY₂ and RETURN. In thecase of monopolar output, the preferred connections would be activeelectrode (e.g., pencil or other probe) to the ENERGY₂ output and asuitable return pad connected to the RETURN output.

Additional details are disclosed in U.S. Patent Application PublicationNo. 2017/0086914, titled TECHNIQUES FOR OPERATING GENERATOR FORDIGITALLY GENERATING ELECTRICAL SIGNAL WAVEFORMS AND SURGICALINSTRUMENTS, which published on Mar. 30, 2017, which is hereinincorporated by reference in its entirety.

As used throughout this description, the term “wireless” and itsderivatives may be used to describe circuits, devices, systems, methods,techniques, communications channels, etc., that may communicate datathrough the use of modulated electromagnetic radiation through anon-solid medium. The term does not imply that the associated devices donot contain any wires, although in some aspects they might not. Thecommunication module may implement any of a number of wireless or wiredcommunication standards or protocols, including but not limited to Wi-Fi(IEEE 802.11 family), WiMAX (IEEE 802.16 family), IEEE 802.20, long termevolution (LTE), Ev-DO, HSPA+, HSDPA+, HSUPA+, EDGE, GSM, GPRS, CDMA,TDMA, DECT, Bluetooth, Ethernet derivatives thereof, as well as anyother wireless and wired protocols that are designated as 3G, 4G, 5G,and beyond. The computing module may include a plurality ofcommunication modules. For instance, a first communication module may bededicated to shorter range wireless communications such as Wi-Fi andBluetooth and a second communication module may be dedicated to longerrange wireless communications such as GPS, EDGE, GPRS, CDMA, WiMAX, LTE,Ev-DO, and others.

As used herein a processor or processing unit is an electronic circuitwhich performs operations on some external data source, usually memoryor some other data stream. The term is used herein to refer to thecentral processor (central processing unit) in a system or computersystems (especially systems on a chip (SoCs)) that combine a number ofspecialized “processors.”

As used herein, a system on a chip or system on chip (SoC or SOC) is anintegrated circuit (also known as an “IC” or “chip”) that integrates allcomponents of a computer or other electronic systems. It may containdigital, analog, mixed-signal, and often radio-frequency functions—allon a single substrate. A SoC integrates a microcontroller (ormicroprocessor) with advanced peripherals like graphics processing unit(GPU), W-Fi module, or coprocessor. A SoC may or may not containbuilt-in memory.

As used herein, a microcontroller or controller is a system thatintegrates a microprocessor with peripheral circuits and memory. Amicrocontroller (or MCU for microcontroller unit) may be implemented asa small computer on a single integrated circuit. It may be similar to aSoC; an SoC may include a microcontroller as one of its components. Amicrocontroller may contain one or more core processing units (CPUs)along with memory and programmable input/output peripherals. Programmemory in the form of Ferroelectric RAM, NOR flash or OTP ROM is alsooften included on chip, as well as a small amount of RAM.Microcontrollers may be employed for embedded applications, in contrastto the microprocessors used in personal computers or other generalpurpose applications consisting of various discrete chips.

As used herein, the term controller or microcontroller may be astand-alone IC or chip device that interfaces with a peripheral device.This may be a link between two parts of a computer or a controller on anexternal device that manages the operation of (and connection with) thatdevice.

Any of the processors or microcontrollers described herein, may beimplemented by any single core or multicore processor such as thoseknown under the trade name ARM Cortex by Texas Instruments. In oneaspect, the processor may be an LM4F230H5QR ARM Cortex-M4F ProcessorCore, available from Texas Instruments, for example, comprising on-chipmemory of 256 KB single-cycle flash memory, or other non-volatilememory, up to 40 MHz, a prefetch buffer to improve performance above 40MHz, a 32 KB single-cycle serial random access memory (SRAM), internalread-only memory (ROM) loaded with StellarisWare® software, 2 KBelectrically erasable programmable read-only memory (EEPROM), one ormore pulse width modulation (PWM) modules, one or more quadratureencoder inputs (QEI) analog, one or more 12-bit Analog-to-DigitalConverters (ADC) with 12 analog input channels, details of which areavailable for the product datasheet.

In one aspect, the processor may comprise a safety controller comprisingtwo controller-based families such as TMS570 and RM4x known under thetrade name Hercules ARM Cortex R4, also by Texas Instruments. The safetycontroller may be configured specifically for IEC 61508 and ISO 26262safety critical applications, among others, to provide advancedintegrated safety features while delivering scalable performance,connectivity, and memory options.

Modular devices include the modules (as described in connection withFIGS. 3 and 9, for example) that are receivable within a surgical huband the surgical devices or instruments that can be connected to thevarious modules in order to connect or pair with the correspondingsurgical hub. The modular devices include, for example, intelligentsurgical instruments, medical imaging devices, suction/irrigationdevices, smoke evacuators, energy generators, ventilators, insufflators,and displays. The modular devices described herein can be controlled bycontrol algorithms. The control algorithms can be executed on themodular device itself, on the surgical hub to which the particularmodular device is paired, or on both the modular device and the surgicalhub (e.g., via a distributed computing architecture). In someexemplifications, the modular devices' control algorithms control thedevices based on data sensed by the modular device itself (i.e., bysensors in, on, or connected to the modular device). This data can berelated to the patient being operated on (e.g., tissue properties orinsufflation pressure) or the modular device itself (e.g., the rate atwhich a knife is being advanced, motor current, or energy levels). Forexample, a control algorithm for a surgical stapling and cuttinginstrument can control the rate at which the instrument's motor drivesits knife through tissue according to resistance encountered by theknife as it advances.

FIG. 20 is a simplified block diagram of one aspect of the generator1100 for providing inductorless tuning as described above, among otherbenefits. With reference to FIG. 20, the generator 1100 may comprise apatient isolated stage 1520 in communication with a non-isolated stage1540 via a power transformer 1560. A secondary winding 1580 of the powertransformer 1560 is contained in the isolated stage 1520 and maycomprise a tapped configuration (e.g., a center-tapped or non-centertapped configuration) to define drive signal outputs 1600 a, 1600 b,1600 c for outputting drive signals to different surgical devices, suchas, for example, an ultrasonic surgical device 1104 and anelectrosurgical device 1106. In particular, drive signal outputs 1600 a,1600 b, 1600 c may output a drive signal (e.g., a 420V RMS drive signal)to an ultrasonic surgical device 1104, and drive signal outputs 1600 a,1600 b, 1600 c may output a drive signal (e.g., a 100V RMS drive signal)to an electrosurgical device 1106, with output 1600 b corresponding tothe center tap of the power transformer 1560. The non-isolated stage1540 may comprise a power amplifier 1620 having an output connected to aprimary winding 1640 of the power transformer 1560. In certain aspectsthe power amplifier 1620 may comprise a push-pull amplifier, forexample. The non-isolated stage 1540 may further comprise a programmablelogic device 1660 for supplying a digital output to a digital-to-analogconverter (DAC) 1680, which in turn supplies a corresponding analogsignal to an input of the power amplifier 1620. In certain aspects theprogrammable logic device 1660 may comprise a field-programmable gatearray (FPGA), for example. The programmable logic device 1660, by virtueof controlling the power amplifier's 1620 input via the DAC 1680, maytherefore control any of a number of parameters (e.g., frequency,waveform shape, waveform amplitude) of drive signals appearing at thedrive signal outputs 1600 a, 1600 b, 1600 c. In certain aspects and asdiscussed below, the programmable logic device 1660, in conjunction witha processor (e.g., processor 1740 discussed below), may implement anumber of digital signal processing (DSP)-based and/or other controlalgorithms to control parameters of the drive signals output by thegenerator 1100.

Power may be supplied to a power rail of the power amplifier 1620 by aswitch-mode regulator 1700. In certain aspects the switch-mode regulator1700 may comprise an adjustable buck regulator, for example. Asdiscussed above, the non-isolated stage 1540 may further comprise aprocessor 1740, which in one aspect may comprise a DSP processor such asan ADSP-21469 SHARC DSP, available from Analog Devices, Norwood, Mass.,for example. In certain aspects the processor 1740 may control operationof the switch-mode power converter 1700 responsive to voltage feedbackdata received from the power amplifier 1620 by the processor 1740 via ananalog-to-digital converter (ADC) 1760. In one aspect, for example, theprocessor 1740 may receive as input, via the ADC 1760, the waveformenvelope of a signal (e.g., an RF signal) being amplified by the poweramplifier 1620. The processor 1740 may then control the switch-moderegulator 1700 (e.g., via a pulse-width modulated (PWM) output) suchthat the rail voltage supplied to the power amplifier 1620 tracks thewaveform envelope of the amplified signal. By dynamically modulating therail voltage of the power amplifier 1620 based on the waveform envelope,the efficiency of the power amplifier 1620 may be significantly improvedrelative to a fixed rail voltage amplifier scheme. The processor 1740may be configured for wired or wireless communication.

In certain aspects, the programmable logic device 1660, in conjunctionwith the processor 1740, may implement a direct digital synthesizer(DDS) control scheme to control the waveform shape, frequency and/oramplitude of drive signals output by the generator 1100. In one aspect,for example, the programmable logic device 1660 may implement a DDScontrol algorithm by recalling waveform samples stored in adynamically-updated look-up table (LUT), such as a RAM LUT which may beembedded in an FPGA. This control algorithm is particularly useful forultrasonic applications in which an ultrasonic transducer, such as theultrasonic transducer 1120, may be driven by a clean sinusoidal currentat its resonant frequency. Because other frequencies may exciteparasitic resonances, minimizing or reducing the total distortion of themotional branch current may correspondingly minimize or reduceundesirable resonance effects. Because the waveform shape of a drivesignal output by the generator 1100 is impacted by various sources ofdistortion present in the output drive circuit (e.g., the powertransformer 1560, the power amplifier 1620), voltage and currentfeedback data based on the drive signal may be input into an algorithm,such as an error control algorithm implemented by the processor 1740,which compensates for distortion by suitably pre-distorting or modifyingthe waveform samples stored in the LUT on a dynamic, ongoing basis(e.g., in real-time). In one aspect, the amount or degree ofpre-distortion applied to the LUT samples may be based on the errorbetween a computed motional branch current and a desired currentwaveform shape, with the error being determined on a sample-by samplebasis. In this way, the pre-distorted LUT samples, when processedthrough the drive circuit, may result in a motional branch drive signalhaving the desired waveform shape (e.g., sinusoidal) for optimallydriving the ultrasonic transducer. In such aspects, the LUT waveformsamples will therefore not represent the desired waveform shape of thedrive signal, but rather the waveform shape that is required toultimately produce the desired waveform shape of the motional branchdrive signal when distortion effects are taken into account.

The non-isolated stage 1540 may further comprise an ADC 1780 and an ADC1800 coupled to the output of the power transformer 1560 via respectiveisolation transformers 1820, 1840 for respectively sampling the voltageand current of drive signals output by the generator 1100. In certainaspects, the ADCs 1780, 1800 may be configured to sample at high speeds(e.g., 80 Msps) to enable oversampling of the drive signals. In oneaspect, for example, the sampling speed of the ADCs 1780, 1800 mayenable approximately 200× (depending on drive frequency) oversampling ofthe drive signals. In certain aspects, the sampling operations of theADCs 1780, 1800 may be performed by a single ADC receiving input voltageand current signals via a two-way multiplexer. The use of high-speedsampling in aspects of the generator 1100 may enable, among otherthings, calculation of the complex current flowing through the motionalbranch (which may be used in certain aspects to implement DDS-basedwaveform shape control described above), accurate digital filtering ofthe sampled signals, and calculation of real power consumption with ahigh degree of precision. Voltage and current feedback data output bythe ADCs 1780, 1800 may be received and processed (e.g., FIFO buffering,multiplexing) by the programmable logic device 1660 and stored in datamemory for subsequent retrieval by, for example, the processor 1740. Asnoted above, voltage and current feedback data may be used as input toan algorithm for pre-distorting or modifying LUT waveform samples on adynamic and ongoing basis. In certain aspects, this may require eachstored voltage and current feedback data pair to be indexed based on, orotherwise associated with, a corresponding LUT sample that was output bythe programmable logic device 1660 when the voltage and current feedbackdata pair was acquired. Synchronization of the LUT samples and thevoltage and current feedback data in this manner contributes to thecorrect timing and stability of the pre-distortion algorithm.

In certain aspects, the voltage and current feedback data may be used tocontrol the frequency and/or amplitude (e.g., current amplitude) of thedrive signals. In one aspect, for example, voltage and current feedbackdata may be used to determine impedance phase, e.g., the phasedifference between the voltage and current drive signals. The frequencyof the drive signal may then be controlled to minimize or reduce thedifference between the determined impedance phase and an impedance phasesetpoint (e.g., 0°), thereby minimizing or reducing the effects ofharmonic distortion and correspondingly enhancing impedance phasemeasurement accuracy. The determination of phase impedance and afrequency control signal may be implemented in the processor 1740, forexample, with the frequency control signal being supplied as input to aDDS control algorithm implemented by the programmable logic device 1660.

The impedance phase may be determined through Fourier analysis. In oneaspect, the phase difference between the generator voltage V_(g)(t) andgenerator current I_(g)(t) driving signals may be determined using theFast Fourier Transform (FFT) or the Discrete Fourier Transform (DFT) asfollows:

V_(g)(t) = A₁cos (2 π f₀t + φ₁) I_(g)(t) = A₂cos (2 π f₀t + φ₂)${V_{g}(f)} = {\frac{A_{1}}{2}\left( {{\delta\left( {f - f_{0}} \right)} + {\delta\left( {f + f_{0}} \right)}} \right){\exp\left( {j\; 2\;\pi\; f\frac{\varphi_{1}}{2\;\pi\; f_{0}}} \right)}}$${I_{g}(f)} = {\frac{A_{2}}{2}\left( {{\delta\left( {f - f_{0}} \right)} + {\delta\left( {f + f_{0}} \right)}} \right){\exp\left( {j\; 2\;\pi\; f\frac{\varphi_{2}}{2\;\pi\; f_{0}}} \right)}}$

Evaluating the Fourier Transform at the frequency of the sinusoidyields:

${V_{g}\left( f_{0} \right)} = {{\frac{A_{1}}{2}{\delta(0)}\mspace{11mu}{\exp\left( {j\;\varphi_{1}} \right)}\mspace{14mu}\arg\mspace{11mu}{V\left( f_{0} \right)}} = \varphi_{1}}$${I_{g}\left( f_{0} \right)} = {{\frac{A_{2}}{2}{\delta(0)}\mspace{11mu}{\exp\left( {j\;\varphi_{2}} \right)}\mspace{14mu}\arg\mspace{11mu}{I\left( f_{0} \right)}} = \varphi_{2}}$

Other approaches include weighted least-squares estimation, Kalmanfiltering, and space-vector-based techniques. Virtually all of theprocessing in an FFT or DFT technique may be performed in the digitaldomain with the aid of the 2-channel high speed ADC 1780, 1800, forexample. In one technique, the digital signal samples of the voltage andcurrent signals are Fourier transformed with an FFT or a DFT. The phaseangle φ at any point in time can be calculated by:φ=2πft+φ ₀

Where φ is the phase angle, f is the frequency, t is time, and φ₀ is thephase at t=0.

Another technique for determining the phase difference between thevoltage V_(g)(t) and current I_(g)(t) signals is the zero-crossingmethod and produces highly accurate results. For voltage V_(g)(t) andcurrent I_(g)(t) signals having the same frequency, each negative topositive zero-crossing of voltage signal V_(g)(t) triggers the start ofa pulse, while each negative to positive zero-crossing of current signalI_(g)(t) triggers the end of the pulse. The result is a pulse train witha pulse width proportional to the phase angle between the voltage signaland the current signal. In one aspect, the pulse train may be passedthrough an averaging filter to yield a measure of the phase difference.Furthermore, if the positive to negative zero crossings also are used ina similar manner, and the results averaged, any effects of DC andharmonic components can be reduced. In one implementation, the analogvoltage V_(g)(t) and current I_(g)(t) signals are converted to digitalsignals that are high if the analog signal is positive and low if theanalog signal is negative. High accuracy phase estimates require sharptransitions between high and low. In one aspect, a Schmitt trigger alongwith an RC stabilization network may be employed to convert the analogsignals into digital signals. In other aspects, an edge triggered RSflip-flop and ancillary circuitry may be employed. In yet anotheraspect, the zero-crossing technique may employ an eXclusive OR (XOR)gate.

Other techniques for determining the phase difference between thevoltage and current signals include Lissajous figures and monitoring theimage; methods such as the three-voltmeter method, the crossed-coilmethod, vector voltmeter and vector impedance methods; and using phasestandard instruments, phase-locked loops, and other techniques asdescribed in Phase Measurement, Peter O'Shea, 2000 CRC Press LLC,<http://www.engnetbase.com>, which is incorporated herein by reference.

In another aspect, for example, the current feedback data may bemonitored in order to maintain the current amplitude of the drive signalat a current amplitude setpoint. The current amplitude setpoint may bespecified directly or determined indirectly based on specified voltageamplitude and power setpoints. In certain aspects, control of thecurrent amplitude may be implemented by control algorithm, such as, forexample, a proportional-integral-derivative (PID) control algorithm, inthe processor 1740. Variables controlled by the control algorithm tosuitably control the current amplitude of the drive signal may include,for example, the scaling of the LUT waveform samples stored in theprogrammable logic device 1660 and/or the full-scale output voltage ofthe DAC 1680 (which supplies the input to the power amplifier 1620) viaa DAC 1860.

The non-isolated stage 1540 may further comprise a processor 1900 forproviding, among other things, user interface (UI) functionality. In oneaspect, the processor 1900 may comprise an Atmel AT91 SAM9263 processorhaving an ARM 926EJ-S core, available from Atmel Corporation, San Jose,Calif., for example. Examples of UI functionality supported by theprocessor 1900 may include audible and visual user feedback,communication with peripheral devices (e.g., via a Universal Serial Bus(USB) interface), communication with a foot switch 1430, communicationwith an input device 2150 (e.g., a touch screen display) andcommunication with an output device 2140 (e.g., a speaker). Theprocessor 1900 may communicate with the processor 1740 and theprogrammable logic device (e.g., via a serial peripheral interface (SPI)bus). Although the processor 1900 may primarily support UIfunctionality, it may also coordinate with the processor 1740 toimplement hazard mitigation in certain aspects. For example, theprocessor 1900 may be programmed to monitor various aspects of userinput and/or other inputs (e.g., touch screen inputs 2150, foot switch1430 inputs, temperature sensor inputs 2160) and may disable the driveoutput of the generator 1100 when an erroneous condition is detected.

FIG. 21 illustrates a generator circuit 3500 partitioned into multiplestages where a first stage circuit 3504 is common to the second stagecircuit 3506, in accordance with at least one aspect of the presentdisclosure. In one aspect, the surgical instruments of surgical system1000 described herein may comprise generator circuit 3500 partitionedinto multiple stages. For example, the surgical instruments of surgicalsystem 1000 may comprise the generator circuit 3500 partitioned into atleast two circuits: the first stage circuit 3504 and the second stagecircuit 3506 of amplification enabling operation of high-frequency (RF)energy only, ultrasonic energy only, and/or a combination of RF energyand ultrasonic energy. A combination modular shaft assembly 3514 may bepowered by a common first stage circuit 3504 located within the handleassembly 3512 and a modular second stage circuit 3506 integral to themodular shaft assembly 3514. As previously discussed throughout thisdescription in connection with the surgical instruments of surgicalsystem 1000, a battery assembly 3510 and the shaft assembly 3514 areconfigured to mechanically and electrically connect to the handleassembly 3512. The end effector assembly is configured to mechanicallyand electrically connect the shaft assembly 3514.

As shown in the example of FIG. 21, the battery assembly 3510 portion ofthe surgical instrument comprises a first control circuit 3502, whichincludes the control circuit 3200 previously described. The handleassembly 3512, which connects to the battery assembly 3510, comprises acommon first stage drive circuit 3420. As previously discussed, thefirst stage drive circuit 3420 is configured to drive ultrasonic,high-frequency (RF) current, and sensor loads. The output of the commonfirst stage drive circuit 3420 can drive any one of the second stagecircuits 3506 such as the second stage ultrasonic drive circuit 3430,the second stage high-frequency (RF) current drive circuit 3432, and/orthe second stage sensor drive circuit 3434. The common first stage drivecircuit 3420 detects which second stage circuit 3506 is located in theshaft assembly 3514 when the shaft assembly 3514 is connected to thehandle assembly 3512. Upon the shaft assembly 3514 being connected tothe handle assembly 3512, the common first stage drive circuit 3420determines which one of the second stage circuits 3506 (e.g., the secondstage ultrasonic drive circuit 3430, the second stage RF drive circuit3432, and/or the second stage sensor drive circuit 3434) is located inthe shaft assembly 3514. The information is provided to the controlcircuit 3200 located in the handle assembly 3512 in order to supply asuitable digital waveform to the second stage circuit 3506 to drive theappropriate load, e.g., ultrasonic, RF, or sensor. It will beappreciated that identification circuits may be included in variousassemblies 3516 in third stage circuit 3508 such as the ultrasonictransducer 1120, the electrodes 3074 a, 3074 b, or the sensors 3440.Thus, when a third stage circuit 3508 is connected to a second stagecircuit 3506, the second stage circuit 3506 knows the type of load thatis required based on the identification information.

FIG. 22 illustrates a diagram of a surgical system 4000, whichrepresents one aspect of the surgical system 1000, comprising a feedbacksystem for use with any one of the surgical instruments of surgicalsystem 1000, which may include or implement many of the featuresdescribed herein. The surgical system 4000 may include a generator 4002coupled to a surgical instrument that includes an end effector 4006,which may be activated when a clinician operates a trigger 4010. Invarious aspects, the end effector 4006 may include an ultrasonic bladeto deliver ultrasonic vibration to carry out surgicalcoagulation/cutting treatments on living tissue. In other aspects theend effector 4006 may include electrically conductive elements coupledto an electrosurgical high-frequency current energy source to carry outsurgical coagulation or cauterization treatments on living tissue andeither a mechanical knife with a sharp edge or an ultrasonic blade tocarry out cutting treatments on living tissue. When the trigger 4010 isactuated, a force sensor 4012 may generate a signal indicating theamount of force being applied to the trigger 4010. In addition to, orinstead of a force sensor 4012, the surgical instrument may include aposition sensor 4013, which may generate a signal indicating theposition of the trigger 4010 (e.g., how far the trigger has beendepressed or otherwise actuated). In one aspect, the position sensor4013 may be a sensor positioned with an outer tubular sheath orreciprocating tubular actuating member located within the outer tubularsheath of the surgical instrument. In one aspect, the sensor may be aHall-effect sensor or any suitable transducer that varies its outputvoltage in response to a magnetic field. The Hall-effect sensor may beused for proximity switching, positioning, speed detection, and currentsensing applications. In one aspect, the Hall-effect sensor operates asan analog transducer, directly returning a voltage. With a knownmagnetic field, its distance from the Hall plate can be determined.

A control circuit 4008 may receive the signals from the sensors 4012and/or 4013. The control circuit 4008 may include any suitable analog ordigital circuit components. The control circuit 4008 also maycommunicate with the generator 4002 and/or a transducer 4004 to modulatethe power delivered to the end effector 4006 and/or the generator levelor ultrasonic blade amplitude of the end effector 4006 based on theforce applied to the trigger 4010 and/or the position of the trigger4010 and/or the position of the outer tubular sheath described aboverelative to a reciprocating tubular actuating member located within anouter tubular sheath (e.g., as measured by a Hall-effect sensor andmagnet combination). For example, as more force is applied to thetrigger 4010, more power and/or higher ultrasonic blade amplitude may bedelivered to the end effector 4006. According to various aspects, theforce sensor 4012 may be replaced by a multi-position switch.

According to various aspects, the end effector 4006 may include a clampor clamping mechanism. When the trigger 4010 is initially actuated, theclamping mechanism may close, clamping tissue between a clamp arm andthe end effector 4006. As the force applied to the trigger increases(e.g., as sensed by force sensor 4012) the control circuit 4008 mayincrease the power delivered to the end effector 4006 by the transducer4004 and/or the generator level or ultrasonic blade amplitude broughtabout in the end effector 4006. In one aspect, trigger position, assensed by position sensor 4013 or clamp or clamp arm position, as sensedby position sensor 4013 (e.g., with a Hall-effect sensor), may be usedby the control circuit 4008 to set the power and/or amplitude of the endeffector 4006. For example, as the trigger is moved further towards afully actuated position, or the clamp or clamp arm moves further towardsthe ultrasonic blade (or end effector 4006), the power and/or amplitudeof the end effector 4006 may be increased.

According to various aspects, the surgical instrument of the surgicalsystem 4000 also may include one or more feedback devices for indicatingthe amount of power delivered to the end effector 4006. For example, aspeaker 4014 may emit a signal indicative of the end effector power.According to various aspects, the speaker 4014 may emit a series ofpulse sounds, where the frequency of the sounds indicates power. Inaddition to, or instead of the speaker 4014, the surgical instrument mayinclude a visual display 4016. The visual display 4016 may indicate endeffector power according to any suitable method. For example, the visualdisplay 4016 may include a series of LEDs, where end effector power isindicated by the number of illuminated LEDs. The speaker 4014 and/orvisual display 4016 may be driven by the control circuit 4008. Accordingto various aspects, the surgical instrument may include a ratchetingdevice connected to the trigger 4010. The ratcheting device may generatean audible sound as more force is applied to the trigger 4010, providingan indirect indication of end effector power. The surgical instrumentmay include other features that may enhance safety. For example, thecontrol circuit 4008 may be configured to prevent power from beingdelivered to the end effector 4006 in excess of a predeterminedthreshold. Also, the control circuit 4008 may implement a delay betweenthe time when a change in end effector power is indicated (e.g., byspeaker 4014 or visual display 4016), and the time when the change inend effector power is delivered. In this way, a clinician may have amplewarning that the level of ultrasonic power that is to be delivered tothe end effector 4006 is about to change.

In one aspect, the ultrasonic or high-frequency current generators ofthe surgical system 1000 may be configured to generate the electricalsignal waveform digitally such that the desired using a predeterminednumber of phase points stored in a lookup table to digitize the waveshape. The phase points may be stored in a table defined in a memory, afield programmable gate array (FPGA), or any suitable non-volatilememory.

Advanced Energy Device Control Algorithms

Various control algorithms for ultrasonic surgical instruments andcombination energy surgical instruments (e.g., ultrasonic/monopolarsurgical instruments, monopolar/bipolar surgical instruments,ultrasonic/bipolar surgical instruments, and other such combinationenergy devices) are described herein. For the sake of clarity, surgicalinstruments will be referenced as surgical instrument 7012 in thissection of the present disclosure, although the disclosure of thissection could also apply to other surgical instruments referenced abovesuch as surgical instrument 112, 700.

In various aspects, a control algorithm for an ultrasonic surgicalinstrument 7012 can be configured to apply a variable clamp arm pressureover the cycle time or the tissue coagulation/cut process of a surgicaloperation to create a constant proximal-to-distal pressure profile. Theconstant pressure profile means that each portion of tissue held withinthe end effector of surgical instrument 7012 along the proximal todistal end of the end effector experiences the same or substantiallysame pressure resulting from the force applied by the end effector clamparm. This may advantageously result in better coagulation of surgicallycut tissue. The control algorithm can be applied by a control circuitand/or a surgical hub. The constant proximal-to-distal pressure profilemay involve applying the control algorithm to vary the pressure appliedby the clamp arm to provide a threshold control pressure at the cutprogression location. The cut progression location can be represented bythe progression of a corresponding weld/coagulation focal pointdetermined by the control circuit and/or surgical hub. Thus, thepressure may be varied based on the focal point. The threshold controlpressure may be a constant pressure applied to the tissue regardless ofthe amount of the end effector that is active. That is, the appliedpressure does not change (or at least does not significantly change)despite any changes in the extent of tissue loading of the end effector.

A tissue bite or portion of tissue may be loaded into the end effectorfor surgical treatment, such as by loading the distal end of the endeffector with tissue first. In this way, contact may initially be madeat a distal point of the end effector. A distal portion of one or moreof the ultrasonic blade and clamp arm could grasp the tissue at thisdistal point. The initial pressure applied by the clamp arm may bedetermined or adjusted (e.g., from a default pressure level) by acontrol circuit and/or surgical hub based on the size of the tissue biteinitially being grasped, which corresponds to an amount of the bladebeing utilized at the start (an initial tissue loading of the endeffector). After surgical cutting of tissue, surgicalcoagulation/sealing may be performed by the surgical instrument 7012,such as by ultrasonic vibration of the ultrasonic blade and/or deliveryof an RF electrical signal waveform output from the generator to RFelectrodes. In the coagulation process, the progression of the weld maybe used to adjust the applied clamp pressure. Specifically, the pressureof the clamp arm can adjust over the progression of the weld as thecut/weld focal point shifts along the blade.

In order to better grasp the tissue at the distal point, one or more ofthe blade and clamp arm could be biased or offset to create apreferential initial contact point at the distal end. Subsequently, theremaining portion of the clamp arm may then be broadly loaded in adistal to proximal manner. Stated differently, in this distal startclosure stroke configuration, the offset ultrasonic blade may deflect soas to fully close against the tissue and clamp arm fully at the endeffector distal end followed by deflecting further in the proximaldirection. The deflections of the blade and clamp arm may beapproximately equal or balanced relative to each other. The distal startclosure stroke configuration is described in more detail below. Theclamp arm pressure can also be varied from the initial pressure by thecontrol circuit and/or surgical hub based on the degree that the endeffector is loaded with the tissue and the progression through the weld.Also, the clamp arm pressure can be varied based on the measured tissueimpedance (e.g., via a pressure, resistive, or other suitable sensor 788in the end effector). Moreover, depending on which energy modality ormodalities of the surgical instrument 7012 are selected, the power levelof one or more of RF and ultrasonic energy delivered to the end effectorcan also be varied based on the measured tissue impedance. Other typesof electrosurgical energy besides RF and ultrasonic energy could also beused.

As discussed above, the tissue loading might commence at the tip ordistal end of the end effector such that the first contact between theultrasonic blade and the clamp arm is at the tip. The surgical huband/or control circuit can be configured to vary pressure applied by theclamp arm based on the extent of blade utilization, which could bedetermined via position sensor 784 (referred to in this portion of thepresent disclosure as position sensor 784, although position sensor 784may also refer to position sensor 734, 4013 or others as describedabove). In particular, the application of clamp pressure can becontrolled so that the clamp arm and ultrasonic blade do not applypressure at portions of the end effector that do not contain tissue. Inother words, the application of clamp pressure is tailored to thoseportions of the end effector in which tissue is located between theultrasonic blade and clamp arm. This may advantageously reducetemperatures and heat residing in the ultrasonic blade after activationof the generator of the surgical instrument 7012. To elaborate further,when the generator delivers energy to the end effector, the portions ofthe end effector in which tissue is not located receive a relativelylower force so energy delivered to these portions is reduced.Consequently, after activating the generator, the peak temperatures andheat of the ultrasonic blade are reduced.

This targeted application of force by the clamp arm can be achievedbased on motorized or manual closure control, tip first closure of theend effector, and feedback provided to the control circuit and/orsurgical hub. The feedback could include thermally induced changes inthe resonant frequency and electrical continuity (or discontinuity). Thefeedback could be received by the control circuit via circuitry thatcomprises the ultrasonic blade and a clamp arm/ultrasonic bladeinterface (e.g., clamp tissue pad). The changes or shift in the resonantfrequency of the transducer may be used as feedback to determine theextent of the tissue loading. In this way, the feedback may be used toadjust applied clamp pressure. Furthermore, the control circuit maycontrol the motor of the surgical instrument to implement the closurestroke so that the end effector closes at a point which is distal to theproximal-most point of the grasped tissue. In this way, a gap may bemaintained between the clamp arm and ultrasonic blade at a point whichis proximal to the proximal-most point of the grasped tissue.

Sensors 788 (referenced as sensors 788 in this portion of the presentdisclosure, although they could also refer to sensors 738 or othersensors described above) of the surgical instrument 7012 may provide endeffector closure signals as input to the control circuit. Using thisinput, the control circuit can determine the current closure position ofthe end effector. When the control circuit determines that the endeffector is merely closed at the tip portions (e.g., distal tip orproximal tip) or at some other sub-portion of the end effector length(e.g., the distal half of the end effector), the control circuit mayreduce displacement of the ultrasonic blade. To this end, power providedto the ultrasonic transducer may be reduced. This reduction indisplacement might beneficially prevent or reduce excessive wear of theclamp arm tissue pad at the distal tip. This excessive wear generally iscaused by high distal forces or pressure at the distal tip(corresponding to the distal start closure stroke configuration) andinherent high distal displacement corresponding to displacement profilesassociated with ultrasonic blades.

In general, when the tissue does not fully occupy the space between thejaws of the end effector, reducing the surface area of the clamp armbeing compressed against the blade reduces the wasteful transmission ofelectrosurgical energy (e.g., including ultrasonic and RF energy) to theclamp arm and/or tissue pad. In other words, the adjustment in clamp armpressure enables relatively more electrosurgical energy to be directedtowards the tissue rather than undesirably being transmitted to otherparts of the end effector. Because the pressure applied by the clamp armis controlled based on the extent of tissue loading, a constant pressuremay be applied to the tissue regardless of how much of the end effectoris in an active state. The pressure may further be adjusted based onprogression of the surgical coagulation/cutting treatment by thesurgical instrument 7012.

Furthermore, the feedback circuitry comprising the ultrasonic blade andclamp pad can also comprise sensor 788 for sensing impedance of thetissue located between the clamp arm and the ultrasonic blade. In thiscase, the ultrasonic blade and associated waveguide that terminates atthe blade could serve as part of the return path for the feedbackcircuitry. The sensed impedance can indicate a status of thecoagulation/cut cycle. That is, for example, comparing the tissueimpedance to a threshold may be indicative of a weld progression of thetissue, such as a progression of the weld/coagulation focal point. Thefocal point may be indicative of how well formed a fibrin clot is forcoagulation, for example. In this way, the detected tissue impedance canenable the control circuit and/or surgical hub to adjust power providedto the ultrasonic transducer and the force applied by the clamp arm.

Although at least some portion of the control algorithm(s) disclosedherein can be performed by surgical hubs (alone or in conjunction withassociated control circuits of surgical instruments), the functions ofthe control algorithm(s) are described as performed by control circuitsfor the sake of clarity. Also for clarity, the control circuit ofsurgical instrument 7012 in this portion of the present disclosure islabeled control circuit 710, although control circuit 710 can be thesame or similar to control circuits 760, 3200, 3502, 4008. Controlcircuit 710 may be a part of the generator 4002 itself (referred to asgenerator 4002 for clarity although generator 4002 can be the same orsimilar to generator 140, 145, 240, 721, 771, 900, 1100) or another partof the surgical instrument 7012 that is remote from the generator 4002.In various aspects, the surgical instrument 7012 (e.g, ultrasonicsurgical instrument) as described in FIGS. 23A-23B, 24A-24B, 25-26,27A-27C, 28A-28C, 29A-29C, 30A-30D, 31A-31D, 32A-32E, is configured tooperate with situational awareness in a hub environment, such as thesurgical hub 106 or 206 (FIGS. 1-11), for example, as depicted by thetimeline 5200.

FIG. 23A-23B are graphs 203000, 203020 including a graph of clamp forceas a function of time and an associated graph of a coagulation/cut focalpoint, in accordance with at least one aspect of the present disclosure.In FIG. 23A, the y-axis 203010 denotes force while the x-axis 203008denotes time. The dashed line 203002 represents the force applied by theclamp arm over time and tracks the application of force by the clamp armfrom the minimum force at time t₀ to maximum force at time t₁₀. Clampforce may be measured in suitable units, such as pounds (lbs). The timespanning initial time t₀ to time t₁₀ can define a surgical cycle of thesurgical instrument 7012. The dash-and-dot line 203004 represents themeasured tissue impedance over the surgical cycle. As can be seen ongraph 203000, the measured tissue impedance decreases from its initiallevel at time t₀ to the low point at time t₃, demonstrating the drop inimpedance resulting from the commencement of surgical treatment (theso-called “bathtub” portion of the impedance curve). After time t₃, thetissue impedance line 203004 rises as the tissue being treated begins todry out. This desiccation results in an increase in tissue impedance.FIG. 23A shows how this increase in tissue impedance line 203004corresponds to an increase in the applied force line 203002. Theincrease in applied force may assist in cutting the tissue and weldingthe denatured tissue as the surgical cycle is completed.

In particular, the control circuit 710 may execute the control algorithmto provide a constant proximal-to-distal pressure profile. By providingsuch a threshold control pressure, the tissue seal formed during thecoagulation stage advantageously may be more uniform and secure.Accordingly, the solid line 203006, which indicates a measured pressureapplied to the tissue in the end effector, stays the same or roughlyconstant throughout the surgical cycle. The tissue pressure line 203006may correspond to the pressure applied at the leading edge of the endeffector, where surgical coagulation and cutting occur. Clamp force canbe a function of the progress of the tissue coagulation process. Thisrelationship may be used to provide the constant tissue pressure. Thus,while tissue may be coagulated and cut at the proximal sections of theend effector, increasing clamp force at the distal section results inbetter coupling of the tissue to the distal sections of the ultrasonicblade. In this way, each section of tissue (which spans the proximal todistal sections of the end effector) could experience the same orapproximately similar pressure. As the tissue weld progresses, thecontrol circuit may control the clamp arm to progressive closure, whichis demonstrated by graph 203000. Also, the clamp arm may be cambered tothe ultrasonic wave guide that terminates into the ultrasonic blade.

FIG. 23B shows that the focal point of the surgical coagulation andcutting operation on the tissue shifts along the length of ultrasonicblade 203026 (similar to or the same as ultrasonic blade 718, 768 orother ultrasonic blades described above) over the course of the surgicalcycle. As shown in FIG. 23B, the focal point shifts in a proximal todistal direction over time, but the focal point could also shift in adistal to proximal direction. The former possibility corresponds to aproximal start closure stroke configuration while the latter correspondsto a distal start closure stroke configuration. As discussed above, thecontrol circuit 710 may be configured to determine the cut/weld focalpoint based on one or more of the resonant frequency and electricalcontinuity feedback measures. Graph 203020 also portrays clamp arm203022 (similar to the same as clamp arm 716, 766 or other clamp armsdescribed above). Clamp arm 203022 can comprise clamp tissue pad 203024,which may be formed from TEFLON® or some other suitable low-frictionmaterial. The pad 203024 may be mounted for cooperation with the blade203026, with pivotal movement of the clamp arm 203022 positioning theclamp pad 203024 in substantially parallel relationship to, and incontact with, the ultrasonic blade 203026. By this construction, atissue bite to be clamped may be grasped between the tissue pad 203024and the ultrasonic blade 203026. The tissue pad 203024 may be providedwith a sawtooth-like configuration including a plurality of axiallyspaced, proximally extending gripping teeth to enhance the gripping oftissue in cooperation with the ultrasonic blade 203026. The controlcircuit 710 may control the clamp arm 203022 to transition from betweenan open position and a closed position, including various intermediatepositions in between. The control circuit 710 may vary the pressureapplied by the clamp arm 203022 based on a shift in the weld focal pointalong the ultrasonic blade 203026 or an extent of tissue loading in theend effector. The x-axis 203028 of graph 203020 represents the surgicalcycle in the same manner that x-axis 203008 does.

FIGS. 24A-24B are graphs 203040, 203060 including a graph 203040 ofclamp force as a function of distance from the distal tip of the endeffector and a graph 203060 of blade displacement as a function ofdistance from the distal tip, in accordance with at least one aspect ofthe present disclosure. FIG. 24A illustrates how the clamp pressurebetween the ultrasonic blade 203026 and clamp arm 203022 varies as afunction of the distance from the distal tip relative to the tissue.Specifically, the graph 203040 includes a plurality of clamp pressurecurves 203042A-203042D showing how the control circuit 710 can adjustthe applied clamp pressure depending on the position of the tissue. Tothis end, the control circuit 710 may determine the closure position ofone or more of the ultrasonic blade 203026 and clamp arm 203022. Thex-axis 203044, 203064 denotes distance from the distal tip of the endeffector while the y-axis 203046, 203066 denotes applied clamp force. Inthe proximal start closure stroke configuration of FIG. 24A, the appliedclamp pressure rolls in a distal direction during the closure motion sothat the closure stroke is at the fully clamped state at the distal tip.Put differently, the clamp pressure may be maximal when the distancefrom the distal tip is minimal. High amplitude of clamp pressure may benecessarily to surgically manipulate the tissue such as manipulating thestructure of a blood vessel as desired.

FIG. 24B illustrates the corresponding displacement profile of theultrasonic blade 203026 as a function of distance from the tip of theend effector. In the graph 203060, the x-axis 203064 again denotesdistance from the distal tip while the y-axis 203066 denotes themagnitude of displacement of the ultrasonic blade 203026. Relatedly, thezero point of the x-axis corresponds an anti-node 203062 while themaximal point corresponds to a node 203068 of the ultrasonic blade203026. The anti-node 203062 can be defined as a local absolute maximumin which the displacement or vibration of the ultrasonic blade 203026 ismaximal. The node 203068 can be defined as a local absolute minimum inwhich the displacement or vibration of the ultrasonic blade 203026 isminimal. In general, the distance between the adjacent node andanti-nodes can be one-quarter wavelength of the drive or resonantfrequency of the ultrasonic blade 203026. As illustrated by the graph203060, at the anti-node 203062, the occurrence of the positive maximumextent of ultrasonic vibration of the ultrasonic blade 203026 overlapswith the maximal distance away from the distal tip. This would alsooccur at the next anti-node corresponding to the negative maximum extentof ultrasonic vibration, although this is not shown in FIG. 24B. At thepoint (node 203068) of minimum distance away from the distal tip, theultrasonic vibration is minimal so as to fully clamp or grasp tissuebetween the ultrasonic blade 203026 and clamp arm 203022. This change inultrasonic displacement as a function of distance of tip is representedby displacement line 203070.

In contrast to the proximal start closure stroke configuration, thepresent disclosure may contemplate a distal start closure strokeconfiguration in which first closing the distal tip of the end effectorultimately assists in advantageously attaining heat mitigation. Heatmitigation can occur by configuring the control circuit 710 to controlclamp pressure according to the extent of tissue loading in the endeffector. Specifically, pressure may be provided only at points ofintersection where ultrasonic blade 203026 and clamp arm 203022 grasptissue therebetween. By preventing or reducing pressure at portions ofthe end effector where no tissue resides, peak temperatures and residualheat after energy delivery from the generator 4002 are reduced. In thisway, relatively more energy is transmitted to the tissue instead of theelectrically conductive clamp arm tissue pad 203024. The clamp pad203024 may be formed of a molded, carbon filled polytetraflouroethyleneor some other suitable material and additionally may be secured to theunderside of clamp arm 203022, as described in U.S. Publication No.2017/0164997, titled METHOD OF TREATING TISSUE USING END EFFECTOR WITHULTRASONIC AND ELECTROSURGICAL FEATURES, published on Jun. 15, 2017,which is herein incorporated by reference in its entirety.

Also, the clamp tissue pad 203024 may be electrically conducive based onthe use of conductive fillers (e.g. carbon, carbon nanotubes, metallicparticles, etc.). Electrical current could flow through the surgicalinstrument 7012 from the ultrasonic blade 203026 to the tissue pad203024 via isolated electrical circuitry, which enables the applicationof therapeutic or sub-therapeutic RF energy to the tissue by the endeffector (e.g., via RF electrode 796). When the surgical instrument 7012includes RF electrode 796, the control circuit 710 can be configured toadjust one or more of a power level of the RF energy and a power levelof the electrosurgical energy based on determined tissue impedance. Moredetails regarding conductive pads may be found in U.S. Pat. No.9,764,164, titled ULTRASONIC SURGICAL INSTRUMENTS, issued on Sep. 19,2017, which is herein incorporated by reference in its entirety. Otheraspects of combination bipolar RF and ultrasonic architectures ofsurgical instrument 7012 are described in U.S. Pat. No. 9,017,326,titled IMPEDANCE MONITORING APPARATUS, SYSTEM, AND METHOD FOR ULTRASONICSURGICAL INSTRUMENTS, issued on Apr. 28, 2015; U.S. Pat. No. 10,022,568,titled DEVICES AND TECHNIQUES FOR CUTTING AND COAGULATING TISSUE, issuedon Jul. 17, 2018; and U.S. Publication No. 2017/0164997, titled METHODOF TREATING TISSUE USING END EFFECTOR WITH ULTRASONIC ANDELECTROSURGICAL FEATURES, published on Jun. 15, 2017, all of which areherein incorporated by reference in their entirety.

The control circuit 710 may control the motor of the surgical instrument7012 to adjust the closure of the clamp arm 203022 and/or the movementof the ultrasonic blade 203026 for heat mitigation and energyefficiency. To this end, only a part of the full length of the endeffector could be used to grasp and treat tissue. For example, only thedistal end of the end effector could initially close on a tissue bitefollowed by progressively more tissue loading in the proximal direction.In this distal start closure stroke configuration, the applied force bythe clamp arm is increased until reaching the full closure strokethreshold while the clamp arm 203022 and/or ultrasonic blade 203026gradually deform to fully compress against tissue while maintaining aslight gap therebetween in portions of the end effector that do notcontain tissue. When the full closure stroke of the end effector isattained, the clamp tissue pad 203024 may contact the entire length ofthe tissue treating portion of the ultrasonic blade 203026. In this way,the control circuit can be configured to close the end effector at adistal end of the end effector prior to closing non-distal end portionsof the end effector. The pressure profile of the tissue treating or endeffecting portion of the ultrasonic blade 203026 is described in moredetail below.

An offset, sloping, or otherwise curved ultrasonic blade 203026 canassist in facilitating distal tip first closure of the clamp arm 203022.More detail regarding closing the distal tip of the end effector first(distal start closure stroke configuration) and the offset ultrasonicblade 203026 may be found in U.S. Pat. No. 8,444,663, titled ULTRASONICSURGICAL SHEARS AND TISSUE PAD FOR THE SAME, issued on May 21, 2013;U.S. Pat. No. 10,004,527, titled ULTRASONIC SURGICAL INSTRUMENT WITHSTAGED CLAMPING, issued on Jun. 26, 2018; U.S. Publication No.2018/0153574, titled HEADPIECE AND BLADE CONFIGURATIONS FOR ULTRASONICSURGICAL INSTRUMENT, published on Jun. 7, 2018; U.S. Publication No.2018/0153574, titled HEADPIECE AND BLADE CONFIGURATIONS FOR ULTRASONICSURGICAL INSTRUMENT, issued on Jun. 7, 2018; and U.S. Publication No.2018/0014848, titled ULTRASONIC SURGICAL INSTRUMENTS HAVING OFFSETBLADES, published on Jan. 18, 2018, all of which are herein incorporatedby reference in their entirety. As discussed above, the ultrasonic blade203026 and/or clamp arm 203022 may be compliant so that the controlcircuit 710 causes the ultrasonic blade 203026 and/or clamp arm 203022to deform as the applied clamp force increases. FIGS. 32A-32E illustratehow this deformation may occur as tissue treatment proceeds. In general,the end effector should be in a full closure state prior to applicationof electrosurgical energy. Also, a first deflection of the offsetultrasonic blade can correspond to a second deflection of the offsetclamp arm. The first and second deflection could be shaped according toa closure pressure profile implemented by the control circuit 710 toprovide relatively greater pressure in the proximal portion of the endeffector.

The control circuit 710 may use feedback to control the end effector forheat mitigation as described above. For example, the control circuit 710could monitor the resonant frequency of the ultrasonic blade 203026. Inparticular, the generator 4002 may include a tuning inductor for tuningout the static capacitance at a resonant frequency so that substantiallyall of generator's current output flows into the motional branch. Themotional branch current, along with the drive voltage, define theimpedance and phase magnitude. Accordingly, the current output of thegenerator 4002 represents the motional branch current, thus enabling thegenerator 4002 to maintain its drive output at the ultrasonictransducer's resonant frequency. The control circuit 710 can monitordrive signals of the generator 4002 that correlate to the resonantfrequency. The generator 4002 may deliver electrosurgical energy to theend effector to weld tissue based on generating the drive signal. As asurgical treatment cycle proceeds, the resonant frequency changes due tochanges in the material stiffness of the tissue. In turn, the change inmaterial stiffness occurs because of the rapid accumulation of thermalenergy in the ultrasonic blade 203026, as electrosurgical energy isbeing delivered.

The control circuit 710 is configured to evaluate this dynamic thermalresponse via frequency changes or frequency slope (e.g., firstderivative of frequency or frequency change with respect to time), suchas based on comparison to a frequency threshold parameter value.Additionally or alternatively, the control circuit 710 can compare thechange in resonant frequency relative to an initial frequency valuedetermined at the start of electrosurgical energy activation, which canbe recorded to the memory of the surgical instrument 7012. Based onelectrical signals generated by the generator 4002, the control circuit710 may determine and compare frequency slope or frequency changesagainst corresponding thresholds. Specifically, the control circuit 710may determine: (i) when the frequency slope is above the associatedthreshold parameter value and (ii) when the frequency change is above afrequency floor. Above a frequency floor means, for example, that thedrop in frequency does not exceed a predetermined threshold droprelative to the determined initial frequency value. Based on one or moreof these determinations, the control circuit 710 (e.g., via the motor)can control the ultrasonic blade 203026 and/or clamp arm 203022 toreduce closure force/stroke when the frequency monitoring conditions(i), (ii) are met. As such, the control circuit 710 may determine aresonant frequency measure indicative of a thermally induced change inresonant frequency to calculate a tissue weld/seal focal point.

In this way, the control circuit 710 causes the applied clamp force orpressure to “back off”, to beneficially minimize the delivery of thermalenergy to the clamp pad 203024 at locations that are proximal to theproximal extent of the grasped tissue. More details regarding resonantfrequency monitoring can be found in U.S. Pat. No. 8,512,365, titledSURGICAL INSTRUMENTS, issued Aug. 20, 2013; and U.S. Pat. No. 9,788,851,titled SURGICAL INSTRUMENT WITH TISSUE DENSITY SENSING, issued on Oct.17, 2017; both of which are herein incorporated by reference in theirentirety. Furthermore, the control circuit 710 can be programmed tofollow a set limit defining the permissible extent to which the controlcircuit 710 backs off on closure force or stroke. The set limit could bedetermined in order to prevent tissue from slipping out or otherwiseescaping from the grasp of the end effector. In addition, the surgicalinstrument 7012 could be designed to provide user feedback such asvisual, audible, tactile, haptic, vibratory, or some other feedback tothe user that is indicative of the current closure state. For example,the user feedback (e.g., light emitting diode, graphical user interface,buzzer, computer generated sound, handle vibration etc.) might indicatewhen the end effector closes at a point proximal the proximal extent ofthe grasped tissue. In situations where the user selects an overridesetting for overriding the automatic closure control feature of thesurgical instrument 7012, this user feedback can be particularly helpfulto inform the user of closure status.

As another example of feedback, the control circuit 710 could monitorthe electrical impedance of the surgical instrument 7012. In variousaspects, the surgical instrument 7012 may conduct electrical currentbetween the ultrasonic blade 203026 and the clamp arm tissue pad 203024for delivery of electrosurgical energy. By monitoring this electricalcurrent (or lack thereof), tissue impedance, or transducer impedancebased on an end effector sensor 788 and/or drive signal of generator4002, the control circuit 710 may determine the amount of tissue loadingin the end effector. In particular, the control circuit 710 may beprogrammed to detect and maintain an impedance of the circuit comprisingthe blade 203026 and the clamp arm tissue pad 203024 above apredetermined threshold. This maintained impedance can correspond orapproximately correspond to an electrical short. As such, the electricalshort means electrical discontinuity exists between the ultrasonic blade203026 and the clamp arm tissue pad 203024. Therefore, minimal thermalenergy is delivered to the portion of the clamp arm tissue pad 203024located proximally to the proximal extent of the grasped tissue. Toarrive at this desired lack of electrical continuity, the controlcircuit 710 could perform the reduction or backing off of the closureforce or stroke as described above. As such, the control circuit 710 maydetermine an electrical continuity measure to calculate a tissueweld/seal focal point.

On the other hand, when the end effector is not fully closed, thefeedback received by the control circuit 710 may be used to reduce theoutput of the generator 4002. The output of the generator 4002 might beultrasonic and/or bipolar RF electrosurgical energy, depending on theenergy modality configuration of the surgical instrument 7012. Byreducing the ultrasonic displacement of ultrasonic blade 203026 and/orRF power conducted via RF electrode 796, the control circuit 710 mayprevent or lower instances of relatively high power densities at thedistal tip of the end effector. This is especially true given that theultrasonic vibration of ultrasonic blade 203026 is generally relativelyhigh at the distal tip. In any case, avoiding these high power densitiesmay advantageously stop or reduce excessive wearing or deterioration ofthe clamp arm tissue pad 203024. The acoustic drive impedance of theultrasonic blade 203026 could also be used to assess jaw closure state.Additionally or alternatively, a closure switch of the surgicalinstrument 7012 such as a handle closure switch could indicate when theclamp arm 203022 and/or ultrasonic blade 203026 is closed, as describedfor example in U.S. Pat. No. 9,724,118, titled TECHNIQUES FOR CUTTINGAND COAGULATING TISSUE FOR ULTRASONIC SURGICAL INSTRUMENTS, issued onAug. 8, 2017, which is herein incorporated by reference in its entirety.Position sensor 734 or motor current also could be used to determine jawclosure state.

FIG. 25 is a graph 203080 of a clamp force distribution as a function ofvarious sections along the length of the end effector, in accordancewith at least one aspect of the present disclosure. The x-axis 203082denotes a section along the length of the end effector, includingsection numbers 1 through 5. The y-axis 203084 denotes gradients ofpressure measured in suitable units ranging from 1 through 4. The unitscould be pounds (lbs), for example. Section 1 represents the distal-mostportion while section 4 represents the proximal-most portion of the endeffector. The measured force can be determined by the control circuit710 based on the sensor 788, such as a pressure sensor. The pressureoutput signal of pressure sensor 788 used to generate graph 203080 hasbeen averaged or summed to smooth the clamp pressure line 203086. Inother words, peaks and valleys in the pressure line 203086 that mightresult from irregularities in the pad 203024 (e.g., teeth in the clamppad 203024) or sensor 788 are softened or smoothed out in graph 203080.As illustrated by graph 203080, the force distribution in the proximalhalf of the end effector is relatively higher than the forcedistribution in the distal half of the end effector. In other words, thepressure profile ratio of the end effector is below the value 1.

The pressure profile ratio can be defined as the sum of pressure appliedin the distal portion divided by the sum of pressure applied in theproximal portion of the end effector. Therefore, pressure profileratios>1 indicate that the end effector is distal tip loaded whilepressure profile ratios<1 indicate proximal loaded status. A distal tiploaded end effector may have more cumulative pressure on the distal halfwhile a proximal loaded end effector has more cumulative pressure on theproximal half. As demonstrated by graph 203080, the end effectormeasured by pressure sensor 788 is proximally loaded. The proximallyloaded status may be assessed from a position in which no tissue iscontained within the end effector. One such example can be seen in FIG.32A. The relatively higher force applied in the proximal portion of theend effector may result from the greater degree of curvature or offsetbetween the ultrasonic blade 203026 and clamp arm 203022 in the distalportion relative to the proximal portion. Proximally loading the endeffector may be desirable because the ultrasonic blade 203026 generallymay ultrasonically vibrate to a greater extent towards to the distalportions. That is, the displacement of the ultrasonic blade 203026 mightbe greater at the distal portion than the proximal portion of the endeffector. The relatively high clamp pressure applied at the proximalportion can advantageously ensure a more uniform application ofelectrosurgical energy to the tissue, thereby attaining a more securecutting/coagulation surgical treatment.

FIG. 26 is a graph 203100 of blade displacement profile as a function ofdistance from the distal tip of the end effector, in accordance with atleast one aspect of the present disclosure. The x-axis 203102 denotesdistance from the distal tip of the end effector, which is shown inunits of millimeters (mm) on graph 203100. The y-axis 203104 denotes thenormalized velocity (on a scale ranging from 0 to 1) of the ultrasonicblade 203026. When normalized, the velocity profile as shown in 203100is coterminous or overlaps with the displacement profile of theultrasonic blade 203026. In addition, the driven resonant frequency203108 of the ultrasonic blade 203026 defines the effective wavelengthof the displacement or velocity profile. As shown in FIG. 26, the drivenresonant frequency 203108 is 55.5 kilohertz (kHz), although othersuitable resonant frequency values are possible as well. The drivenresonant frequency 203108 is a factor of the material, geometry, andthermal condition of the surgical instrument 7012. Also shown in FIG. 26is the tissue treatment border 203110 of the end effector. The tissuetreatment border 203110 indicates the length of the tissue treating(e.g., cutting and coagulation) portion of the end effector and isapproximately 15 mm from the distal tip in graph 203100. Thevelocity-distance line 203106 represents the change in normalizedvelocity as a function of distance from the distal tip.

Stated another way, the tissue treating portion spans 15 mm from thedistal tip of the end effector, as measured in the proximal direction.The velocity and/or displacement profile as portrayed in graph 203100demonstrates that the velocity and/or displacement of the ultrasonicblade 203026 is maximal at the distal tip and decreases to the minimalvalue as the distance from the distal tip increases to the maximum.Accordingly, providing a preferential distribution of clamp forcetowards the proximal portion of the end effector as shown in FIG. 25,can allow for a more uniform power deposition along the length of theend effector. Power deposition is a function of the coefficient offriction, the velocity, and the applied force or pressure. Thus, asdiscussed above, matching the relatively high distal velocity to arelatively low distal pressure and matching the relatively low proximalvelocity to a relatively high proximal pressure can result in moreuniform cutting of tissue, as determined with respect to time. When theend effector is fully closed such that it has reached the full closurestroke, the resulting pressure or force profile is higher in theproximal half or quarter of the end effector, so graph 203080 shows howthe pressure or force profile ratio is <1. Also, the deflections of theultrasonic blade 203026 and clamp arm 203022 can be equivalent or matchover the course of the closure stroke of the end effector.

FIGS. 27A-27C are sectional views of end effector 203120 that illustratea closure stroke of the end effector, in accordance with at least oneaspect of the present disclosure. The progression of the closure strokeas portrayed in FIGS. 27A-27C demonstrates a proximal startconfiguration closure stroke. In FIG. 27A, the end effector 203120(which may be the same or similar to end effectors described above,including end effector 702, 752, 792, 4006) is at a more open positionthan in FIGS. 27B-27C. Clamp arm 203122 includes clamp arm tissue pad203124, which may be the same or similar as pad 203024. In FIG. 27A, theclamp arm 203122 is spaced away from the ultrasonic blade 203126 so thatclamp arm tissue pad 203124 initially begins to contact or touch theblade at the most proximal portion of the clamp arm tissue pad 203124.The clamp arm 203122 is sloped or angled upwards relative to ahorizontal axis defined by the end effector 203120. Accordingly, theopening between the clamp arm 203122 and ultrasonic blade 203126increases in the distal direction away from pivot point 203128. Theclamp arm 203122 and ultrasonic blade 203126 may pivot about pivot point203128.

Although FIG. 27A does not depict tissue grasped by the end effector203120, in operation, tissue may be located in end effector 203120 suchthat the end effector 203120 compresses against tissue at theproximal-most extent of pad 203124 to being tissue treatment in FIG.27A. In FIG. 27B, the clamp arm 203122 is further along in the closurestroke of the end effector 203120. As such, most or all of the proximalportion of the end effector is in the closed position. Accordingly, FIG.27B shows that the proximal-most extent of the pad 203124 contacts theultrasonic blade 203126, while the portions of the pad 203124immediately distal to the proximal-most extent are also almost closed orcontacting the ultrasonic blade 203126. Again, the gap between the clamparm 203122 and the ultrasonic blade 203126 increases in the distaldirection away from pivot point 203128. FIG. 27C illustrates the fullclosure position of the end effector 203120. In FIG. 27C, the fullextent of the clamp arm 203122 and pad 203124 contacts the ultrasonicblade 203126 to obtain the full closure stroke. Thus, clamp pressure isapplied to all portions of the end effector 203120, as reflected in FIG.28C. The closure progression of the proximal start configuration asdepicted in FIGS. 27A-27C demonstrates how clamp pressure or force rollsin the distal direction.

FIGS. 28A-28C are graphs 203140, 203160, 203180 of clamp force appliedbetween the blade and clamp arm as a function of distance from thedistal tip of the end effector 203120 corresponding to the sectionalviews of FIGS. 27A-27C, in accordance with at least one aspect of thepresent disclosure. The applied clamp pressure or force plotted ingraphs 203140, 203160, 203180 can be measured by pressure sensor 788. Inthe graphs 203140, 203160, 203180, the x-axis 203144, 203164, 203184denotes the distance from the distal tip of end effector 203120. They-axis 203146, 203166, 203186 denotes the clamp arm pressure or forceapplied between the clamp arm 203122 and the ultrasonic blade 203126.The applied clamp force line 203142, 203162, 203184 illustrates theclamp pressure as a function of distance from the distal tip of endeffector 203120. As described above, the applied clamp pressure firstbegins at the proximal-most extent of clamp arm tissue pad 203124,adjacent to pivot point 203128. This is demonstrated by FIG. 28A. InFIG. 28B, the clamp pressure has begun to spread distally. Accordingly,the applied clamp force line 203162 starts at a more leftward point thanthat of applied clamp force line 203142. Moreover, the clamp pressure atthe proximal-most extent of clamp arm tissue pad 20312 is greater inFIG. 28B than in FIG. 28A. That is, the amplitude at the rightmostportion of the applied clamp force line 203162 is greater than thecorresponding amplitude of applied clamp force line 203142.

In FIG. 28C, the applied clamp force line 203182 starts at an even moreleftward point than that of applied clamp force line 203162. In fact,clamp pressure is applied at all points spanning the x-axis 203184. Theclamp pressure at the proximal-most extent of clamp arm tissue pad 20312is greater in FIG. 28C than either of FIG. 28B and FIG. 28A. The graph203180 of FIG. 28C illustrates the applied pressure in a full closurestroke or position of the end effector 203120. In the full closure stateof the end effector 203120, it may be desirable for the control circuit710 to implement computer executable logic or rules that ensure the endeffector 203120 reaches the full closure stroke prior to application ofenergy by the generator 4002. As discussed above, the full closurestroke is achieved when the end effector 203120 closes along its entireavailable length. By delivering electrosurgical energy to the tissueonly after attaining the full closure position, better tissue sealingmay be performed. In particular, homeostasis can be maximized orimproved based on the full closure stroke laterally displacing the innerlayers and approximating the outer layers of the tissue so that theselayers may be joined during delivery of electrosurgical energy. That is,optimum vessel sealing may occur when the inner muscle layer of a vesselis separated and moved away from the adventitia layer prior to theapplication of electrosurgical energy. The outer tissue layers couldform more reliable tissue welds or seals (e.g., tunica adventitia,serosal covering, etc.).

One example of such rules executed by the control circuit 710 includes arule in which if the user activates the large vessel or advancedhemostasis mode of the surgical instrument 7012, the control circuit 710verifies that the end effector 203120 has reaches the full closurestroke. This verification could occur via a handle closure or fullclosure switch of the surgical instrument 7012, for example. When theclosure switch is not in the closed position, this indicates the endeffector 203120 is not fully closed. Consequently, the surgicalinstrument 7012 may generate an alert such as an audible beeping soundor visual, audible, tactile, haptic, vibratory alert, or some othersuitable alert. In some aspects, the surgical instrument 7012 may havemechanical components to control application of relatively high clampforce for displacing vessel structure (e.g., approximating adventitia)and of relatively low clamp force for energy delivery. More detailsregarding such rules and vessel structure manipulation for cutting andsealing tissue may be found in U.S. Pat. No. 8,779,648, titledULTRASONIC DEVICE FOR CUTTING AND COAGULATING WITH STEPPED OUTPUT,issued on Jul. 15, 2014; U.S. Pat. No. 9,241,728, titled SURGICALINSTRUMENT WITH MULTIPLE CLAMPING MECHANISMS, issued on Jan. 26, 2016;U.S. Pat. No. 9,743,947, titled END EFFECTOR WITH A CLAMP ARM ASSEMBLYAND BLADE, issued on Aug. 29, 2017; all of which are herein incorporatedby reference in their entirety.

FIGS. 29A-29C are sectional views of the end effector 203200 thatillustrate a proximal start closure stroke configuration, in accordancewith at least one aspect of the present disclosure. As shown in FIG.29A, the end effector 203200 starts in an open position in which clamparm 203202 and ultrasonic blade 203206 define a relatively large gap inbetween each other. Clamp arm 203202 includes clamp arm tissue pad203204, which may the same or similar as pad 203024, 203124. In FIG.29B, the clamp arm 203202 has pivoted inwards with respect to pivotpoint 203208 so that the proximal portion of clamp arm tissue pad 203204contacts tissue (not shown) located on the pad 203204. In other words,the end effector 203200 closes proximally first so as to apply fullclamp pressure to only the proximal portion of the grasped tissue whileclamp force progressively rolls or expands in the distal direction. Asthe end effector 203000 reaches the full closure stroke depicted in FIG.29C, more clamp pressure is gradually distally. In FIG. 29C, the fullclosure pressure profile or force distribution is achieved in the fullclosure position of end effector 203000. As discussed above, relativelymore clamp pressure can be applied in the proximal portion of the endeffecting portion of the ultrasonic blade 203026 to account for therelatively low proximal velocity of the ultrasonic blade 203026, forexample.

FIGS. 30A-30D are sectional views of the end effector 203220 thatillustrate a distal start closure stroke configuration and indicateassociated part stresses, in accordance with at least one aspect of thepresent disclosure. In the distal start closure stroke configuration,the end effector 203220 first closes at the distal tip, as illustratedin FIG. 30A and as described above. Thus, the control circuit isconfigured to control closure of the clamp arm 203224 by pivoting theclamp arm 203224 to create an initial contact point of the ultrasonicblade 203226 and clamp arm 203224 at a distal end of the end effector203220. In FIG. 30A, the distal tip of clamp arm 203224 contactsultrasonic blade 203226. In this way, the clamp arm tissue pad 203224 ofclamp arm 203224 compresses against the grasped tissue at the distalportion first. Unlike in FIGS. 29A-29C, the applied clamp pressure inFIGS. 30A-30D rolls in the proximal direction. Also, the ultrasonicblade 203226 may be curved, sloped, or otherwise offset to allow forclosing at the distal tip first. FIG. 30B depicts the end effector203220 starting to apply more clamp pressure at the clamp arm tissue pad203224, moving in the proximal direction. As such, the contours 203228illustrate the associated part stresses in response to this increasedbending of the clamp arm 203224. FIG. 30C shows the continuedprogression of the applied clamp pressure, in which a majority of thetissue treating portion of the end effector 203220 is in the fullycompression position. The tissue treating portion may refer to theportion of the end effector that includes the clamp arm tissue pad203224. As can be seen in FIGS. 30A-30D, the pad 203224 does not extendto the intersection between the clamp arm 203224 and ultrasonic blade203226 at the proximal portion of end effector 203220. Based on thisconfiguration, the end effector has a slight proximal gap 203230, whichcan be beneficial for heat mitigation as described above.

In FIG. 30D, the end effector 203220 has achieved the full closurestroke, while advantageously maintaining the proximal gap 203230. As theend effector 203220 progressively approaches a full closure position,one or more of the clamp arm 203224 and ultrasonic blade 203226progressively realizes greater part stresses arising from the increasedbending force that is exerted. In accordance, the part stressesgradually increase in correspondence with the transition from FIGS. 30A,30C, 30C to 30D. Consequently, the greatest occurrence of contours203228 occurs in FIG. 30D. As illustrated in FIGS. 30A-30D and moving ina proximal direction, incrementally more of the clamp arm tissue pad203224 becomes active as more of the end effector 203220 closes. Thedepicted closure sequence culminates in FIG. 30D in which the entireavailable surface area of pad 203224 is used to compress against graspedtissue and ultrasonic blade 203226 while the portion of the end effector203220 that is proximal to the proximal extent of the pad 203224 andgrasped tissue defines the proximal gap 203230. Although the pad 203224may terminate at the distal-most extent of the proximal gap 203230, thepad 203224 could also extend into the proximal gap 203230. Even wherethe pad 203224 extends in this way, the clamp arm 203222 is recessed toassist in defining the proximal gap 203230. In the proximal gap 203230,less electrosurgical energy is delivered, which may advantageouslyreduce the temperatures and heat residing in the ultrasonic blade 203226after activating energy delivery by the generator 4002. The controlcircuit 710 may be configured to execute matching or correspondingdeflections of the clamp arm 203224 and ultrasonic blade 203226 suchthat each of the clamp arm 203224 and ultrasonic blade 203226 deform,deflect, or bend to the same extent in transitioning from theconfiguration of FIG. 30A to FIG. 30D.

Moreover, the applied clamp pressure as well as displacement andvelocity of ultrasonic blade 203226 can be controlled depending on theprogression of the closure stroke. For example, when the end effector203220 is only closed at the distal tip or approximately only the distalportion (e.g., in FIGS. 30A-30B), the displacement and/or velocity ofthe ultrasonic blade 203226 can be reduced in order to prevent excessivewear or deterioration of the pad 203224. Thus, ultrasonic oscillationcan be reduced when the end effector 203220 is not fully closed. Asdescribed above, displacement may be relatively high at the distal tipportion, so reduction in blade displacement may be desirable for thedistal start closure configuration of the end effector 203220.Additionally, the control circuit 710 may be configured to controlclosure of one or more of the clamp arm 203222 and ultrasonic blade203226 to vary the pressure applied to provide a threshold controlpressure based on the cut progression location (e.g., corresponding weldfocal point). For example, as the end effector 203220 advances fromFIGS. 30A to 30D, a surgical cut or coagulation focal point may shiftalong the length of the ultrasonic blade 203226, which can be used toadjust applied clamp pressure. The shift may be proximal or distal,depending on the selected closure stroke configuration, for example.When the focal point is at the center portion of the distal half of theend effector 203220, for example, relatively more pressure may beapplied at that center portion while relative less pressure might beapplied at locations distal to the center portion.

Additionally or alternatively to adjustments to clamp arm forces basedon cut/coagulation focal point, the control circuit 710 may generallyapply a relatively lower distal pressure and higher proximal force toaddress the displacement or velocity profile of the ultrasonic blade203226. As discussed above, the displacement or velocity of theultrasonic blade 203226 is relatively higher at distal portions, soapplied forces may be lower at those portions compared to proximalportions. The ultrasonic blade 203226 may be made of a suitablematerial, such as titanium metal or alloy. More specifically, thetitanium alloy could be a grade 5 alpha/beta titanium alloy such asTi-6Al-4V or it could be some other suitable metal. The clamp arm 203224could also be made of a suitable material such as stainless steel andmore particularly, a precipitation-hardened 17-4 stainless steel. Also,the clamp arm tissue pad 203224 may be electrically conductive based onconductive fillers (e.g., carbon, carbon nanotubes, metallic particles)so that the surgical instrument 7012 can conduct electrical current fromthe ultrasonic blade 203226 to the pad 203224 via isolated electricalconduits after the end effector 203220 is fully closed. This way,electrosurgical energy such as therapeutic or sub-therapeutic RF can bedelivered to the grasped tissue.

FIGS. 31A-31D are graphs 203240, 203260, 203280, 203300 of clamp forceapplied between the ultrasonic blade 203226 and clamp arm 203224 as afunction of distance from the distal tip of the end effector 203220corresponding to the sectional views of FIGS. 30A-30D, in accordancewith at least one aspect of the present disclosure. The graphs 203240,203260, 203280, 203300 contain legends 203250, 203270, 203290, 203310,respectively, which has different dot patterns denoting the associateddegree of force due to compression between the ultrasonic blade 203226and clamp arm 203224, for example. Pressure contours 203308 are plottedalong the corresponding blade models 203252, 203272, 203292, 203312,which are a generic depiction of the length of ultrasonic blade 203226.The pressure contours 203308 may be indicative of the amount andlocation of component stresses applied relative to the distance awayfrom the distal tip of the end effector 203220. The dotted line 203254,203274, 203294, 203314 denotes the proximal end of the tissue effectingportion (e.g., the proximal end of the pad 203224) of the end effector203220. As can be seen in FIGS. 31A-31D, the pressure contours 203308start at the distal tip of the end effector 203220 and transitionproximally towards the dotted line 203254, 203274, 203294, 203314. Inthe graphs 203240, 203260, 203280, 203300, the x-axis 203244, 203264,203284, 203304 denotes the distance from the distal tip of the endeffector 203220.

The y-axis 203246, 203266, 203286, 203306 denotes the applied clampforce resulting from contact between the ultrasonic blade 203226 andclamp arm 203224. The applied force is represented by the applied forceline 203242, 203262, 203282, 203302. In FIG. 14A, the applied clampforce only occurs at the distal tip, which corresponds to the distal tipfirst closure of the distal start closure stroke configuration. Theapplication of the clamp force gradually shifts proximally, asillustrated by the change in applied force line 203242, 203262, 203282,203302 from FIGS. 31A to 31D. Furthermore, the amplitude of the appliedclamp force also gradually increases from FIGS. 31A to 31D. The graphs203240, 203260, 203280, 203300 may display a similar progression inclamp force as that depicted in FIGS. 28A-28C, except that the twoseries of graphs progress in opposite directions. Nonetheless, thedistributed force or pressure profile depicted in graph 203300 maymirror that of graph 203180. That is, although FIGS. 31A to 31D depictapplied pressure transitioning proximally while FIGS. 28A-28C depictpressure transitioning distally, the force profile when the full closurestroke is achieved is the same or similar regardless of the selectedclosure stroke configuration. The component stresses of the closurestroke according to FIGS. 31A-31D are represented by indicators 203248,203268, 203288, 203308. Additionally, the position sensor 784 or othersensor 788 could be used to detect the vessel location along the lengthof the ultrasonic blade 203226 for grasped tissue. This detection mightbe used to adjust the closure stroke in real-time so as to target theblood vessel for application of maximum force on top of the vessel. Thisdetection could also be used to refrain from applying power intoportions of the end effector 203220 that do not contact tissue. Thiscould be useful for heat mitigation.

FIGS. 32A-32E are sectional views of the end effector 203340 thatillustrate a distal start closure stroke configuration and indicateassociated part stresses, in accordance with at least one aspect of thepresent disclosure. As can be seen in FIG. 32A-32E, the ultrasonic blade203346 is curved and is deformable so that the curvature of ultrasonicblade 203346 flattens or bottoms out in the full closure stroke, asdepicted in FIGS. 32D-32E. Accordingly, the axis of ultrasonic blade203346 is offset. The ultrasonic blade 203346 and clamp arm 203342 pivotabout pivot point 203348. The clamp arm 203342 includes clamp arm tissuepad 203344. FIGS. 32A-32E illustrate the progression of distal tip firstclosure on tissue 203350 for application of electrosurgical energythrough pad 203344. In FIG. 32B, the distal tip of curved ultrasonicblade 203346 contacts the distal tip of clamp arm 203342 based onpivoting one or more of ultrasonic blade 203346 and clamp arm 203342toward each other. The ultrasonic blade 203346 and clamp arm 203342 maymove approximately an equal distance towards each other during theduration of the closure stroke. The end effector 203340 may compressagainst the proximal-most extent of the tissue 203350 at this point. Thecontrol circuit 710 may be configured to determine an initial clamppressure to be applied based on the size of the tissue 203350 initiallyloaded into end effector 203340.

As can be seen in FIGS. 32B-32C, the deflection of curved ultrasonicblade 203346 continues and rolls proximally. Simultaneously, more of thetissue 203350 is grasped. The deflection may comprise bottoming out thecurved ultrasonic blade 203346 by incrementally reducing theinstantaneous curvature of the curved ultrasonic blade 203346. At FIG.32D, the curved ultrasonic blade 203346 is fully bottomed out such thatthe end effector 203340 is fully closed (i.e, reached the full closurestroke). A portion of the grasped tissue 203350 is fully compressedagainst the ultrasonic blade 203346 and clamp arm 203342 in the fullclosure position so that electrosurgical energy can be delivered throughthe pad 203344 for cutting and coagulation. The distal to proximal spanof the grasped tissue within the end effector 203340 defines the tissuecontact area. This tissue contact area may generate a significant amountof heat. For thermal mitigation or reduction, instead of fully bottomingout, the end effector 203340 maintains a deflection of the ultrasonicblade 203346 that is proximal to the proximal most portion of the tissuecontact area. This is shown in FIGS. 32A-32E. Thus, the control circuit7012 may maintain a gap between the ultrasonic blade 203346 and clamparm 203342 at a point proximal to a proximal end of the tissue. Ascompared to the fully closed position depicted in FIG. 32D, the portionsof the pad 203344 that are not treating tissue (the portions of pad203344 proximal to the proximal-most extent of tissue contact area) donot receive as much thermal energy. Consequently, peak temperatures andheat residing in the ultrasonic blade 203346 after application ofelectrosurgical energy is reduced.

Also shown in ultrasonic blade 203346 are blade models 203352, 203372,203392, 203412, which illustrate the progression of clamp force alongthe length of the end effector 203340. First dotted line 203356represents the distal tip while second dotted line 203358 represents theproximal end of the end effector 203340. The second dotted line 203358also may represent the proximal-most extent of the tissue 203350 orwhere the tissue 203350 stops. In the blade model 203352, no force isapplied to the ultrasonic blade 203346. In the blade model 203372, thedistal tip of the ultrasonic blade 203346 contacts the correspondingportion of clamp arm 203342, so some force is applied to the distalportion of the ultrasonic blade 203346. Areas of greater applied forcemay be denoted by darker shading of the pressure contours 203376,203396, 203416. Accordingly, relatively high force represented bypressure contour 203376 is applied to the distal tip in blade model203372. In the blade model 203392, the end effector 203340 is morepartially closed in the proximal direction, so the pressure contour203396 spans a greater length of the end effector 203340. The pressurecontour 203396 may vary depending on the location of the cut/weld focalpoint so as to provide a constant threshold pressure on the tissue203350. In the blade model 203392, the end effector 203340 is fullyclosed and applied clamp force has completed moving proximally duringthe closure motion. Consequently, the pressure contour 203396 spans aneven greater length and terminates at the second dotted line 203358.

EXAMPLES

Various aspects of the subject matter described herein are set out inthe following numbered examples:

Example 1

A surgical instrument comprises an end effector, an ultrasonictransducer, a control circuit, and the control circuit coupled to theend effector. The end effector comprises: an ultrasonic blade configuredto ultrasonically oscillate against tissue; and a clamp arm configuredto pivot relative to the ultrasonic blade. The ultrasonic transducer isacoustically coupled to the ultrasonic blade. The ultrasonic transduceris configured to ultrasonically oscillate the ultrasonic blade inresponse to a drive signal from a generator. The end effector isconfigured to receive electrosurgical energy from the generator to treattissue based on the drive signal. The control circuit is configured to:determine one or more of a resonant frequency measure indicative of athermally induced change in resonant frequency and an electricalcontinuity measure; calculate a weld focal point based on one or more ofthe resonant frequency measure and electrical continuity measure;control closure of the clamp arm to vary a pressure applied by the clamparm to provide a threshold control pressure to the tissue loaded intothe end effector, wherein the pressure is varied based on acorresponding weld focal point; and maintain a gap between theultrasonic blade and clamp arm at a point proximal to a proximal end ofthe tissue.

Example 2

The surgical instrument of Example 1, wherein the control circuit isfurther configured to determine an initial pressure applied by the clamparm based on a size of the tissue initially loaded into the endeffector.

Example 3

The surgical instrument of Examples 1 or 2, wherein the control circuitis further configured to vary the pressure applied by the clamp armbased on a shift in the weld focal point along the ultrasonic blade.

Example 4

The surgical instrument of Example 3, wherein the control circuit isfurther configured to vary the pressure applied by the clamp arm basedon an extent of the tissue loaded into the end effector.

Example 5

The surgical instrument of Examples 1, 2, 3, or 4, wherein the controlcircuit is further configured to control closure of the clamp arm bypivoting the clamp arm to create an initial contact point of theultrasonic blade and clamp arm at a distal end of the end effector.

Example 6

The surgical instrument of Examples 1, 2, 3, 4, or 5, further comprisingthe generator configured to deliver electrosurgical energy to the endeffector to treat tissue based on generating the drive signal.

Example 7

The surgical instrument of Examples 1, 2, 3, 4, 5, or 6, furthercomprising a radio frequency (RF) electrode configured to deliver RFenergy to the tissue, wherein the control circuit is further configuredto adjust one or more of a power level of the RF energy and a powerlevel of the electrosurgical energy based on tissue impedancel.

Example 8

A method of using a surgical instrument to provide a threshold controlpressure, wherein the surgical instrument comprises: an end effectorcomprising: a ultrasonic blade configured to ultrasonically oscillateagainst tissue; and a clamp arm configured to pivot relative to theultrasonic blade; an ultrasonic transducer acoustically coupled to theultrasonic blade, the ultrasonic transducer configured to ultrasonicallyoscillate the ultrasonic blade in response to the drive signal; and acontrol circuit coupled to the end effector, wherein the end effector isconfigured to receive electrosurgical energy from a generator to weldtissue based on a generated drive signal and wherein the methodcomprises: determining, by the control circuit, one or more of aresonant frequency measure indicative of a thermally induced change inresonant frequency and a electrical continuity measure; calculating, bythe control circuit, a weld focal point based on one or more of theresonant frequency measure and electrical continuity measure;controlling, by the control circuit, closure of the clamp arm to vary apressure applied by the clamp arm to provide the threshold controlpressure to the tissue loaded into the end effector, wherein thepressure is varied based on a corresponding weld focal point; andmaintaining, by the control circuit, a gap between the ultrasonic bladeand clamp arm at a point proximal to a proximal end of the tissue.

Example 9

The method of Example 8, further comprising determining, by the controlcircuit, an initial pressure applied by the clamp arm based on a size ofthe tissue initially loaded into the end effector.

Example 10

The method of Examples 8 or 9, further comprising varying, by thecontrol circuit, the pressure applied by the clamp arm based on a shiftin the weld focal point along the ultrasonic blade.

Example 11

The method of Example 10, further comprising varying, by the controlcircuit, the pressure applied by the clamp arm based on an extent of thetissue loaded into the end effector.

Example 12

The method of Examples 8, 9, 10, or 11 further comprising controlling,by the control circuit, closure of the clamp arm by pivoting the clamparm to create an initial contact point of the ultrasonic blade and clamparm at a distal end of the end effector.

Example 13

The method of Examples 8, 9, 10, 11, or 12, further comprising loadingthe tissue into the end effector from the distal end to a proximal endof the end effector.

Example 14

The method of Examples 8, 9, 10, 11, 12, or 13, further comprisingadjusting, by the control circuit, one or more of a power level of RFenergy and a power level of the electrosurgical energy based on tissueimpedance, wherein the surgical instrument further comprises a radiofrequency (RF) electrode configured to deliver RF energy to the tissue.

Example 15

A surgical system comprising: a surgical hub configured to receive aclamp pressure algorithm transmitted from a cloud computing system,wherein the surgical hub is communicatively coupled to the cloudcomputing system; and a surgical instrument communicatively coupled tothe surgical hub, wherein the surgical instrument comprises: an endeffector comprising: an offset ultrasonic blade configured toultrasonically oscillate against tissue; and an offset clamp armconfigured to pivot relative to the ultrasonic blade; and an ultrasonictransducer acoustically coupled to the ultrasonic blade, the ultrasonictransducer configured to ultrasonically oscillate the ultrasonic bladein response to a drive signal from a generator, wherein the end effectoris configured to receive electrosurgical energy from the generator toweld tissue based on the drive signal; and a control circuit configuredto perform the clamp pressure algorithm to: determine one or more of aresonant frequency measure indicative of a thermally induced change inresonant frequency and a electrical continuity measure; calculate anextent of tissue loaded into the end effector based on one or more ofthe resonant frequency measure and electrical continuity measure; andvary pressure applied by the clamp arm according to a closure pressureprofile comprising a first pressure in a proximal half of the endeffector that is greater than a second pressure in a distal half of theend effector and to maintain a gap between the ultrasonic blade andclamp arm at a point proximal to a proximal end of the tissue loadedinto the end effector when the end effector is fully closed.

Example 16

The surgical system of Example 15, wherein the control circuit isfurther configured to close the end effector at a distal end of the endeffector prior to closing non-distal end portions of the end effector.

Example 17

The surgical system of Examples 15 or 16, further comprising:terminating, by the generator, application of the third power level fora third dwell time; determining, by the control circuit, a fourth tissueimpedance point; and applying, by the generator, a fourth power level toreach the fourth tissue impedance point.

Example 18

The surgical system of Example 17, wherein the first and seconddeflection are shaped according to the closure pressure profile toprovide the first pressure.

Example 19

The surgical system of Examples 15, 16, 17, or 18, wherein the controlcircuit is further configured to determine a closure position of theclamp arm.

Example 20

The method of Example 19, wherein the control circuit is furtherconfigured to reduce the ultrasonic oscillation of the ultrasonic bladewhen the end effector is not in fully closed.

While several forms have been illustrated and described, it is not theintention of Applicant to restrict or limit the scope of the appendedclaims to such detail. Numerous modifications, variations, changes,substitutions, combinations, and equivalents to those forms may beimplemented and will occur to those skilled in the art without departingfrom the scope of the present disclosure. Moreover, the structure ofeach element associated with the described forms can be alternativelydescribed as a means for providing the function performed by theelement. Also, where materials are disclosed for certain components,other materials may be used. It is therefore to be understood that theforegoing description and the appended claims are intended to cover allsuch modifications, combinations, and variations as falling within thescope of the disclosed forms. The appended claims are intended to coverall such modifications, variations, changes, substitutions,modifications, and equivalents.

The foregoing detailed description has set forth various forms of thedevices and/or processes via the use of block diagrams, flowcharts,and/or examples. Insofar as such block diagrams, flowcharts, and/orexamples contain one or more functions and/or operations, it will beunderstood by those within the art that each function and/or operationwithin such block diagrams, flowcharts, and/or examples can beimplemented, individually and/or collectively, by a wide range ofhardware, software, firmware, or virtually any combination thereof.Those skilled in the art will recognize that some aspects of the formsdisclosed herein, in whole or in part, can be equivalently implementedin integrated circuits, as one or more computer programs running on oneor more computers (e.g., as one or more programs running on one or morecomputer systems), as one or more programs running on one or moreprocessors (e.g., as one or more programs running on one or moremicroprocessors), as firmware, or as virtually any combination thereof,and that designing the circuitry and/or writing the code for thesoftware and or firmware would be well within the skill of one of skillin the art in light of this disclosure. In addition, those skilled inthe art will appreciate that the mechanisms of the subject matterdescribed herein are capable of being distributed as one or more programproducts in a variety of forms, and that an illustrative form of thesubject matter described herein applies regardless of the particulartype of signal bearing medium used to actually carry out thedistribution.

Instructions used to program logic to perform various disclosed aspectscan be stored within a memory in the system, such as dynamic randomaccess memory (DRAM), cache, flash memory, or other storage.Furthermore, the instructions can be distributed via a network or by wayof other computer readable media. Thus a machine-readable medium mayinclude any mechanism for storing or transmitting information in a formreadable by a machine (e.g., a computer), but is not limited to, floppydiskettes, optical disks, compact disc, read-only memory (CD-ROMs), andmagneto-optical disks, read-only memory (ROMs), random access memory(RAM), erasable programmable read-only memory (EPROM), electricallyerasable programmable read-only memory (EEPROM), magnetic or opticalcards, flash memory, or a tangible, machine-readable storage used in thetransmission of information over the Internet via electrical, optical,acoustical or other forms of propagated signals (e.g., carrier waves,infrared signals, digital signals, etc.). Accordingly, thenon-transitory computer-readable medium includes any type of tangiblemachine-readable medium suitable for storing or transmitting electronicinstructions or information in a form readable by a machine (e.g., acomputer).

As used in any aspect herein, the term “control circuit” may refer to,for example, hardwired circuitry, programmable circuitry (e.g., acomputer processor including one or more individual instructionprocessing cores, processing unit, processor, microcontroller,microcontroller unit, controller, digital signal processor (DSP),programmable logic device (PLD), programmable logic array (PLA), orfield programmable gate array (FPGA)), state machine circuitry, firmwarethat stores instructions executed by programmable circuitry, and anycombination thereof. The control circuit may, collectively orindividually, be embodied as circuitry that forms part of a largersystem, for example, an integrated circuit (IC), an application-specificintegrated circuit (ASIC), a system on-chip (SoC), desktop computers,laptop computers, tablet computers, servers, smart phones, etc.Accordingly, as used herein “control circuit” includes, but is notlimited to, electrical circuitry having at least one discrete electricalcircuit, electrical circuitry having at least one integrated circuit,electrical circuitry having at least one application specific integratedcircuit, electrical circuitry forming a general purpose computing deviceconfigured by a computer program (e.g., a general purpose computerconfigured by a computer program which at least partially carries outprocesses and/or devices described herein, or a microprocessorconfigured by a computer program which at least partially carries outprocesses and/or devices described herein), electrical circuitry forminga memory device (e.g., forms of random access memory), and/or electricalcircuitry forming a communications device (e.g., a modem, communicationsswitch, or optical-electrical equipment). Those having skill in the artwill recognize that the subject matter described herein may beimplemented in an analog or digital fashion or some combination thereof.

As used in any aspect herein, the term “logic” may refer to an app,software, firmware and/or circuitry configured to perform any of theaforementioned operations. Software may be embodied as a softwarepackage, code, instructions, instruction sets and/or data recorded onnon-transitory computer readable storage medium. Firmware may beembodied as code, instructions or instruction sets and/or data that arehard-coded (e.g., nonvolatile) in memory devices.

As used in any aspect herein, the terms “component,” “system,” “module”and the like can refer to a computer-related entity, either hardware, acombination of hardware and software, software, or software inexecution.

As used in any aspect herein, an “algorithm” refers to a self-consistentsequence of steps leading to a desired result, where a “step” refers toa manipulation of physical quantities and/or logic states which may,though need not necessarily, take the form of electrical or magneticsignals capable of being stored, transferred, combined, compared, andotherwise manipulated. It is common usage to refer to these signals asbits, values, elements, symbols, characters, terms, numbers, or thelike. These and similar terms may be associated with the appropriatephysical quantities and are merely convenient labels applied to thesequantities and/or states.

A network may include a packet switched network. The communicationdevices may be capable of communicating with each other using a selectedpacket switched network communications protocol. One examplecommunications protocol may include an Ethernet communications protocolwhich may be capable permitting communication using a TransmissionControl Protocol/Internet Protocol (TCP/IP). The Ethernet protocol maycomply or be compatible with the Ethernet standard published by theInstitute of Electrical and Electronics Engineers (IEEE) titled “IEEE802.3 Standard”, published in December, 2008 and/or later versions ofthis standard. Alternatively or additionally, the communication devicesmay be capable of communicating with each other using an X.25communications protocol. The X.25 communications protocol may comply orbe compatible with a standard promulgated by the InternationalTelecommunication Union-Telecommunication Standardization Sector(ITU-T). Alternatively or additionally, the communication devices may becapable of communicating with each other using a frame relaycommunications protocol. The frame relay communications protocol maycomply or be compatible with a standard promulgated by ConsultativeCommittee for International Telegraph and Telephone (CCITT) and/or theAmerican National Standards Institute (ANSI). Alternatively oradditionally, the transceivers may be capable of communicating with eachother using an Asynchronous Transfer Mode (ATM) communications protocol.The ATM communications protocol may comply or be compatible with an ATMstandard published by the ATM Forum titled “ATM-MPLS NetworkInterworking 2.0” published August 2001, and/or later versions of thisstandard. Of course, different and/or after-developedconnection-oriented network communication protocols are equallycontemplated herein.

Unless specifically stated otherwise as apparent from the foregoingdisclosure, it is appreciated that, throughout the foregoing disclosure,discussions using terms such as “processing,” “computing,”“calculating,” “determining,” “displaying,” or the like, refer to theaction and processes of a computer system, or similar electroniccomputing device, that manipulates and transforms data represented asphysical (electronic) quantities within the computer system's registersand memories into other data similarly represented as physicalquantities within the computer system memories or registers or othersuch information storage, transmission or display devices.

One or more components may be referred to herein as “configured to,”“configurable to,” “operable/operative to,” “adapted/adaptable,” “ableto,” “conformable/conformed to,” etc. Those skilled in the art willrecognize that “configured to” can generally encompass active-statecomponents and/or inactive-state components and/or standby-statecomponents, unless context requires otherwise.

The terms “proximal” and “distal” are used herein with reference to aclinician manipulating the handle portion of the surgical instrument.The term “proximal” refers to the portion closest to the clinician andthe term “distal” refers to the portion located away from the clinician.It will be further appreciated that, for convenience and clarity,spatial terms such as “vertical”, “horizontal”, “up”, and “down” may beused herein with respect to the drawings. However, surgical instrumentsare used in many orientations and positions, and these terms are notintended to be limiting and/or absolute.

Those skilled in the art will recognize that, in general, terms usedherein, and especially in the appended claims (e.g., bodies of theappended claims) are generally intended as “open” terms (e.g., the term“including” should be interpreted as “including but not limited to,” theterm “having” should be interpreted as “having at least,” the term“includes” should be interpreted as “includes but is not limited to,”etc.). It will be further understood by those within the art that if aspecific number of an introduced claim recitation is intended, such anintent will be explicitly recited in the claim, and in the absence ofsuch recitation no such intent is present. For example, as an aid tounderstanding, the following appended claims may contain usage of theintroductory phrases “at least one” and “one or more” to introduce claimrecitations. However, the use of such phrases should not be construed toimply that the introduction of a claim recitation by the indefinitearticles “a” or “an” limits any particular claim containing suchintroduced claim recitation to claims containing only one suchrecitation, even when the same claim includes the introductory phrases“one or more” or “at least one” and indefinite articles such as “a” or“an” (e.g., “a” and/or “an” should typically be interpreted to mean “atleast one” or “one or more”); the same holds true for the use ofdefinite articles used to introduce claim recitations.

In addition, even if a specific number of an introduced claim recitationis explicitly recited, those skilled in the art will recognize that suchrecitation should typically be interpreted to mean at least the recitednumber (e.g., the bare recitation of “two recitations,” without othermodifiers, typically means at least two recitations, or two or morerecitations). Furthermore, in those instances where a conventionanalogous to “at least one of A, B, and C, etc.” is used, in generalsuch a construction is intended in the sense one having skill in the artwould understand the convention (e.g., “a system having at least one ofA, B, and C” would include but not be limited to systems that have Aalone, B alone, C alone, A and B together, A and C together, B and Ctogether, and/or A, B, and C together, etc.). In those instances where aconvention analogous to “at least one of A, B, or C, etc.” is used, ingeneral such a construction is intended in the sense one having skill inthe art would understand the convention (e.g., “a system having at leastone of A, B, or C” would include but not be limited to systems that haveA alone, B alone, C alone, A and B together, A and C together, B and Ctogether, and/or A, B, and C together, etc.). It will be furtherunderstood by those within the art that typically a disjunctive wordand/or phrase presenting two or more alternative terms, whether in thedescription, claims, or drawings, should be understood to contemplatethe possibilities of including one of the terms, either of the terms, orboth terms unless context dictates otherwise. For example, the phrase “Aor B” will be typically understood to include the possibilities of “A”or “B” or “A and B.”

With respect to the appended claims, those skilled in the art willappreciate that recited operations therein may generally be performed inany order. Also, although various operational flow diagrams arepresented in a sequence(s), it should be understood that the variousoperations may be performed in other orders than those which areillustrated, or may be performed concurrently. Examples of suchalternate orderings may include overlapping, interleaved, interrupted,reordered, incremental, preparatory, supplemental, simultaneous,reverse, or other variant orderings, unless context dictates otherwise.Furthermore, terms like “responsive to,” “related to,” or otherpast-tense adjectives are generally not intended to exclude suchvariants, unless context dictates otherwise.

It is worthy to note that any reference to “one aspect,” “an aspect,”“an exemplification,” “one exemplification,” and the like means that aparticular feature, structure, or characteristic described in connectionwith the aspect is included in at least one aspect. Thus, appearances ofthe phrases “in one aspect,” “in an aspect,” “in an exemplification,”and “in one exemplification” in various places throughout thespecification are not necessarily all referring to the same aspect.Furthermore, the particular features, structures or characteristics maybe combined in any suitable manner in one or more aspects.

Any patent application, patent, non-patent publication, or otherdisclosure material referred to in this specification and/or listed inany Application Data Sheet is incorporated by reference herein, to theextent that the incorporated materials is not inconsistent herewith. Assuch, and to the extent necessary, the disclosure as explicitly setforth herein supersedes any conflicting material incorporated herein byreference. Any material, or portion thereof, that is said to beincorporated by reference herein, but which conflicts with existingdefinitions, statements, or other disclosure material set forth hereinwill only be incorporated to the extent that no conflict arises betweenthat incorporated material and the existing disclosure material.

In summary, numerous benefits have been described which result fromemploying the concepts described herein. The foregoing description ofthe one or more forms has been presented for purposes of illustrationand description. It is not intended to be exhaustive or limiting to theprecise form disclosed. Modifications or variations are possible inlight of the above teachings. The one or more forms were chosen anddescribed in order to illustrate principles and practical application tothereby enable one of ordinary skill in the art to utilize the variousforms and with various modifications as are suited to the particular usecontemplated. It is intended that the claims submitted herewith definethe overall scope.

The invention claimed is:
 1. A surgical instrument comprising: an endeffector comprising: a ultrasonic blade configured to ultrasonicallyoscillate against tissue; and a clamp arm configured to pivot relativeto the ultrasonic blade; an ultrasonic transducer acoustically coupledto the ultrasonic blade, the ultrasonic transducer configured toultrasonically oscillate the ultrasonic blade in response to a drivesignal from a generator, wherein the end effector is configured toreceive electrosurgical energy from the generator to treat tissue basedon the drive signal; and a control circuit coupled to the end effector,the control circuit configured to: determine one or more of a resonantfrequency measure indicative of a thermally induced change in resonantfrequency and an electrical continuity measure; calculate a weld focalpoint based on one or more of the resonant frequency measure andelectrical continuity measure; control closure of the clamp arm to varya pressure applied by the clamp arm to provide a threshold controlpressure to the tissue loaded into the end effector, wherein thepressure is varied based on a corresponding weld focal point; andmaintain a gap between the ultrasonic blade and clamp arm at a pointproximal to a proximal end of the tissue.
 2. The surgical instrument ofclaim 1, wherein the control circuit is further configured to determinean initial pressure applied by the clamp arm based on a size of thetissue initially loaded into the end effector.
 3. The surgicalinstrument of claim 1, wherein the control circuit is further configuredto vary the pressure applied by the clamp arm based on a shift in theweld focal point along the ultrasonic blade.
 4. The surgical instrumentof claim 3, wherein the control circuit is further configured to varythe pressure applied by the clamp arm based on an extent of the tissueloaded into the end effector.
 5. The surgical instrument of claim 1,wherein the control circuit is further configured to control closure ofthe clamp arm by pivoting the clamp arm to create an initial contactpoint of the ultrasonic blade and clamp arm at a distal end of the endeffector.
 6. The surgical instrument of claim 1, further comprising thegenerator configured to deliver electrosurgical energy to the endeffector to treat tissue based on generating the drive signal.
 7. Thesurgical instrument of claim 1, further comprising a radio frequency(RF) electrode configured to deliver RF energy to the tissue, whereinthe control circuit is further configured to adjust one or more of apower level of the RF energy and a power level of the electrosurgicalenergy based on tissue impedance.
 8. A method of using a surgicalinstrument to provide a threshold control pressure, wherein the surgicalinstrument comprises: an end effector comprising: a ultrasonic bladeconfigured to ultrasonically oscillate against tissue; and a clamp armconfigured to pivot relative to the ultrasonic blade; an ultrasonictransducer acoustically coupled to the ultrasonic blade, the ultrasonictransducer configured to ultrasonically oscillate the ultrasonic bladein response to a drive signal; and a control circuit coupled to the endeffector, wherein the end effector is configured to receiveelectrosurgical energy from a generator to weld tissue based on agenerated drive signal and wherein the method comprises: determining, bythe control circuit, one or more of a resonant frequency measureindicative of a thermally induced change in resonant frequency and anelectrical continuity measure; calculating, by the control circuit, aweld focal point based on one or more of the resonant frequency measureand electrical continuity measure; controlling, by the control circuit,closure of the clamp arm to vary a pressure applied by the clamp arm toprovide the threshold control pressure to the tissue loaded into the endeffector, wherein the pressure is varied based on a corresponding weldfocal point; and maintaining, by the control circuit, a gap between theultrasonic blade and clamp arm at a point proximal to a proximal end ofthe tissue.
 9. The method of claim 8, further comprising determining, bythe control circuit, an initial pressure applied by the clamp arm basedon a size of the tissue initially loaded into the end effector.
 10. Themethod of claim 8, further comprising varying, by the control circuit,the pressure applied by the clamp arm based on a shift in the weld focalpoint along the ultrasonic blade.
 11. The method of claim 10, furthercomprising varying, by the control circuit, the pressure applied by theclamp arm based on an extent of the tissue loaded into the end effector.12. The method of claim 8, further comprising controlling, by thecontrol circuit, closure of the clamp arm by pivoting the clamp arm tocreate an initial contact point of the ultrasonic blade and clamp arm ata distal end of the end effector.
 13. The method of claim 8, furthercomprising loading the tissue into the end effector from a distal end toa proximal end of the end effector.
 14. The method of claim 8, whereinthe surgical instrument further comprises a radio frequency (RF)electrode configured to deliver RF energy to the tissue, and wherein themethod further adjusting, by the control circuit, one or more of a powerlevel of RF energy and a power level of the electrosurgical energy basedon tissue impedance.
 15. A surgical system comprising: a surgical hubconfigured to receive a clamp pressure algorithm transmitted from acloud computing system, wherein the surgical hub is communicativelycoupled to the cloud computing system; and a surgical instrumentcommunicatively coupled to the surgical hub, wherein the surgicalinstrument comprises: an end effector comprising: an offset ultrasonicblade configured to ultrasonically oscillate against tissue; and anoffset clamp arm configured to pivot relative to the ultrasonic blade;and an ultrasonic transducer acoustically coupled to the ultrasonicblade, the ultrasonic transducer configured to ultrasonically oscillatethe ultrasonic blade in response to a drive signal from a generator,wherein the end effector is configured to receive electrosurgical energyfrom the generator to weld tissue based on the drive signal; and acontrol circuit configured to perform the clamp pressure algorithm to:determine one or more of a resonant frequency measure indicative of athermally induced change in resonant frequency and an electricalcontinuity measure; calculate an extent of tissue loaded into the endeffector based on one or more of the resonant frequency measure andelectrical continuity measure; and vary pressure applied by the clamparm according to a closure pressure profile comprising a first pressurein a proximal half of the end effector that is greater than a secondpressure in a distal half of the end effector and to maintain a gapbetween the ultrasonic blade and clamp arm at a point proximal to aproximal end of the tissue loaded into the end effector when the endeffector is fully closed; and close the end effector at a distal end ofthe end effector prior to closing non-distal end portions of the endeffector.
 16. The surgical system of claim 15, wherein a firstdeflection of the offset ultrasonic blade corresponds to a seconddeflection of the offset clamp arm.
 17. The surgical system of claim 16,wherein the first and second deflection are shaped according to theclosure pressure profile to provide the first pressure.
 18. The surgicalsystem of claim 15, wherein the control circuit is further configured todetermine a closure position of the clamp arm.
 19. The surgical systemof claim 18, wherein the control circuit is further configured to reducethe ultrasonic oscillation of the ultrasonic blade when the end effectoris not fully closed.